FEM
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Accessories, Photographic, For Endoscope (Exclude Light Sources)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2021: 47 · 2022: 109 · 2023: 131 · 2024: 108 · 2025: 119 · 2026: 45
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CAMERA COVER WITH TEAR TIP (K940152) | Hydro-Med Products, Inc. | 1994-10-28 |
| POLAROID INSTANT ENDOCAMERA (K812542) | Polaroid Corp. | 1981-10-19 |
| PHOTOGRAPHIC EQUIPMENT (K812201) | Reznik Instruments | 1981-10-19 |
| POLAROID LAND CAMERA FOR ENDOSCOPY (K792512) | Polaroid Corp. | 1979-12-20 |
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Every clearance here is in the API, with alerts when new ones post.