GCP
13 FDA 510(k) clearances · Product code
61 daysmedian time to decision
122 days90th percentile
13clearances measured
FDA profile
- Official device name
- Endoscope, Ac-Powered And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2020: 18 · 2022: 26 · 2023: 100 · 2024: 108 · 2025: 182 · 2026: 62
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 |
|---|---|---|
| EOS BRAND DISPOSABLE PROCTOSCOPE (K954614) | North Eos Industries, Inc. | 1996-04-10 |
| PORGES UNIVERSAL HANDLES (K896505) | Porges Corp. | 1990-01-30 |
| MODEL 6500 MERCURY ARC LIGHT SOURCE (K896008) | Medical Dynamics, Inc. | 1989-12-27 |
| STEERABLE CATHETER SYSTEM (K862424) | Endovations | 1986-09-22 |
| MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE (K860103) | Endotherapeutics | 1986-02-12 |
| MODULAR FIBERSCOPE SYSTEM (K843683) | Reichert Scientific Instruments | 1985-01-18 |
| TAMPONADE BALLOON CUFF (K833859) | American Endoscopy, Inc. | 1984-01-03 |
| ENDOSCOPIC SCLEROTHERAPY BALLOON (K821999) | Retech | 1982-08-27 |
| CCD ENDOSCOPE AND ATTACHMENTS (K801247) | Welch Allyn, Inc. | 1980-07-28 |
| ENDOSCOPE AND ACCESSORIES (K790071) | Olympus Corp. | 1979-04-02 |
| FIBER OPTICS SIGMOIDOSCOPE (K771919) | Propper Mfg. Co., Inc. | 1977-10-20 |
| FIBER OPTICS PROCTOSCOPE (K771920) | Propper Mfg. Co., Inc. | 1977-10-20 |
| FIBEO OPTICS ILLUM. SYSTEM (K771918) | Propper Mfg. Co., Inc. | 1977-10-20 |
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Every clearance here is in the API, with alerts when new ones post.