Apollo Endosurgery, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Apollo Endosurgery, Inc.” (first 2008, latest 2023), plus 1 De Novo decision, across 7 product codes in 1 review panel. Median 510(k) review time under this name: 91 days. Since 2017 the median was 57 days, against 133 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Boston Scientific, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 60 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 142 |
| 2018 | 1 | 57 |
| 2019 | 1 | 91 |
| 2020 | 1 | 167 |
| 2021 | 1 | 29 |
| 2022 | 0 | — |
| 2023 | 2 | 28 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Apollo Endosurgery, Inc. took a median 57 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | 6 | 6 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 2 | 2 |
| QTD | Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss | 2 | 1 |
| KGE | Forceps, Biopsy, Electric | 1 | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 | 1 |
Review panels
Most recent Apollo Endosurgery, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | QTD | 2023-09-18 | 27 |
| K231553 | OverStitch NXT Endoscopic Suturing System | OCW | 2023-06-29 | 30 |
| K210266 | OverStitch Sx Endoscopic Suturing System | OCW | 2021-03-02 | 29 |
| K201808 | X-Tack Endoscopic HeliX Tacking System | PKL | 2020-12-15 | 167 |
| K191439 | OverStitch 2-0 Polypropylene Suture | OCW | 2019-08-29 | 91 |
| K181141 | OverStitch Endoscopic Suturing System and Accessories | OCW | 2018-06-27 | 57 |
| K171886 | OverStitch SX Endoscopic Suturing System (ESS) | OCW | 2017-11-15 | 142 |
| K122270 | OVERTUBE ENDOSCOPIC ACCESS SYSTEM | FED | 2012-09-28 | 60 |
| K103155 | SUMO ACCESS AND TISSUE RESECTION SYSTEM | ODC | 2011-10-28 | 367 |
| K082102 | GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 | FED | 2010-06-14 | 689 |
3 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210045 | De Novo | Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss | 2022-07-12 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2017-11-22.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Apollo Endosurgery, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00953173: HERO Study: Helping Evaluate Reduction in Obesity (Completed, started 2009-12)
- NCT00730327: A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects (Completed, started 2008-06)
- NCT00570505: Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2 (Completed, started 2007-11)
- NCT00501085: LAP-BAND AP Early Experience Trial (APEX) (Completed, started 2007-06)
- NCT00447590: Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents (Completed, started 2007-03)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Apollo Spine, Inc. (7 510(k)s)
- Apollo Enterprise, Ltd. Co. (3 510(k)s)
- Apollo Dental Products, Inc. (2 510(k)s)
- Apollo Medical Imaging Technology Pty. , Ltd. (2 510(k)s)
- Apollo Corp. (1 510(k)s)
- Apollo Fluid Dynamics (1 510(k)s)
- Apollo Medical Optics, Ltd. (1 510(k)s)
- Apollo Physical Therapy Products International (1 510(k)s)
- Apollo Products, Inc. (1 510(k)s)
- Apollo'S Suntanning Supplies (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Apollo Endosurgery, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Apollo Endosurgery, Inc.” (first 2008, latest 2023), plus 1 De Novo decision, across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Apollo Endosurgery, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Apollo Endosurgery, Inc. is 91 days. Since 2017: 57 days, versus 133 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Apollo Endosurgery, Inc.?
The most frequent FDA product codes under this applicant name are OCW (Endoscopic Tissue Approximation Device, 6); FED (Endoscopic Access Overtube, Gastroenterology-Urology, 2); QTD (Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss, 2).
Next steps
- See all 13 Apollo Endosurgery, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCW, Apollo Endosurgery, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.