National Advanced Endoscopy Devices, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “National Advanced Endoscopy Devices, Inc.” (first 1999, latest 2017), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 118 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 212 |
| 2016 | 0 | — |
| 2017 | 1 | 183 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name National Advanced Endoscopy Devices, Inc. took a median 183 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FJL | Resectoscope | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
Review panels
- General and Plastic Surgery (3)
- Gastroenterology and Urology (2)
- Ear, Nose and Throat (1)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
Most recent National Advanced Endoscopy Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170285 | AED Sinuscope | EOB | 2017-08-01 | 183 |
| K141515 | AED HYSTEROSCOPE AND ACCESSORIES | HIH | 2015-01-07 | 212 |
| K102663 | AED RESECTOSCOPE | FJL | 2010-12-30 | 106 |
| K081553 | AED BIPOLAR FORCEPS, MODEL 13-1646 | GEI | 2008-09-29 | 118 |
| K081503 | AED MONOPOLAR LAP ACCESSORIES | GEI | 2008-09-25 | 119 |
| K993689 | AED CYSTOSCOPE | FAJ | 1999-12-15 | 44 |
| K993688 | AED LAPAROSCOPE | GCJ | 1999-12-06 | 35 |
| K991656 | AED ARTHROSCOPE | HRX | 1999-12-02 | 203 |
Recalls
openFDA lists no recalls under a recalling firm named National Advanced Endoscopy Devices, Inc..
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.
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.
- National Medical Care, Medical Products Div., Inc. (62 510(k)s)
- National Patent Development Corp. (34 510(k)s)
- National Biological Corp. (28 510(k)s)
- National Custom Ent., Inc. (12 510(k)s)
- National Catheter Co. Div. Mallinckrodt (8 510(k)s)
- National Healthcare Mfg. Corp. (7 510(k)s)
- National Wire & Stamping, Inc. (5 510(k)s)
- National Health-Care Equipment, Inc. (4 510(k)s)
- National Healthcare Linen Service (4 510(k)s)
- National Medical Technology (4 510(k)s)
- National Display Systems (3 510(k)s)
- National Hearing Aid Dist., Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under National Advanced Endoscopy Devices, Inc.?
FDA lists 8 510(k) clearances under the applicant name “National Advanced Endoscopy Devices, Inc.” (first 1999, latest 2017), across 7 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by National Advanced Endoscopy Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name National Advanced Endoscopy Devices, Inc. is 118 days.
Which FDA product codes appear under National Advanced Endoscopy Devices, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); EOB (Nasopharyngoscope (Flexible Or Rigid), 1); FAJ (Cystoscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 8 National Advanced Endoscopy Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, National Advanced Endoscopy Devices, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.