Stryker Endoscopy: FDA clearances and approvals
Stryker Endoscopy has 102 FDA 510(k) clearances (first 1993, latest 2026), plus 1 De Novo decision, across 29 product codes in 8 review panels. Median 510(k) review time: 86 days. Since 2017 its median was 56 days, against 109 days for all cleared 510(k)s in the same product codes. openFDA lists 278 product recalls by a recalling firm named Stryker Endoscopy. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 110 |
| 2013 | 3 | 101 |
| 2014 | 2 | 72 |
| 2015 | 3 | 58 |
| 2016 | 1 | 100 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 70 |
| 2022 | 2 | 58 |
| 2023 | 3 | 82 |
| 2024 | 6 | 69 |
| 2025 | 5 | 27 |
| 2026 | 6 | 29 |
Review time against the same product codes
Since 2017, Stryker Endoscopy's cleared 510(k)s took a median 56 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 25 | 25 |
| HRX | Arthroscope | 11 | 11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 11 | 11 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 8 |
| HWC | Screw, Fixation, Bone | 7 | 7 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 4 | 4 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 3 | 3 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 3 | 3 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 3 | 3 |
| HET | Laparoscope, Gynecologic (And Accessories) | 3 | 3 |
Plus 19 more product codes.
Review panels
- General and Plastic Surgery (40)
- Orthopedic (38)
- Gastroenterology and Urology (8)
- Obstetrics and Gynecology (6)
- Ear, Nose and Throat (4)
- General Hospital (4)
- Radiology (2)
- Neurology (1)
Most recent Stryker Endoscopy 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down | MBI | 2026-07-30 | 20 |
| K253602 | Precision S 4K Sinuscope | GWG | 2026-06-04 | 198 |
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | IZI | 2026-05-28 | 59 |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | GCJ | 2026-02-18 | 28 |
| K260108 | L12 LED Light Source with AIM | OWN | 2026-02-12 | 29 |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | GCJ | 2026-01-13 | 29 |
| K253888 | MOLLI 2 System | NEU | 2025-12-31 | 27 |
| K252010 | SPY Laparoscope | GCJ | 2025-07-24 | 27 |
| K252012 | SPY Cystoscope/Hysteroscope | HIH | 2025-07-18 | 21 |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | MAI | 2025-05-23 | 87 |
92 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250040 | De Novo | Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System | 2026-07-17 |
Recalls
278 product recalls in 44 recall events; 0 initiated in the last five years. Most recent: 2016-03-28.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Stryker Endoscopy is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06320925: SportsPro: Post-Market Clinical Follow Up Study (Recruiting, started 2023-12-05)
- NCT05329584: InSpace Accelerated Rehabilitation Study (Recruiting, started 2022-02-07)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Stryker Endoscopy's product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Stryker Endoscopy have?
Stryker Endoscopy has 102 FDA 510(k) clearances (first 1993, latest 2026), plus 1 De Novo decision, across 29 product codes in 8 review panels.
How long does FDA take to clear Stryker Endoscopy's 510(k)s?
The median time from FDA receipt to decision across Stryker Endoscopy's cleared 510(k)s is 86 days. Since 2017: 56 days, versus 109 days for all cleared 510(k)s in the same product codes.
What devices does Stryker Endoscopy make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 25); HRX (Arthroscope, 11); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 11).
Has Stryker Endoscopy had device recalls?
openFDA lists 278 product recalls in 44 recall events by a recalling firm whose name matches Stryker Endoscopy; the most recent began 2016-03-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 102 Stryker Endoscopy clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Stryker Endoscopy's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.