GCL
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Esophagoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FE-24X, FIBER ESOPHAGOSCOPE (K951197) | Pentax Precision Instrument Corp. | 1995-05-30 |
| FE-34TH, FIBER ESOPHAGOSCOPE (K951198) | Pentax Precision Instrument Corp. | 1995-05-30 |
| 5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD (K934510) | Phx Technologies Corp. | 1994-02-17 |
| BARD BIOPSY FORCEPS (K922086) | C.R. Bard, Inc. | 1992-10-30 |
Track GCL automatically
Every clearance here is in the API, with alerts when new ones post.