KGEClass II
Forceps, Biopsy, Electric
21 CFR 876.4300 / Gastroenterology, Urology
KGE is the FDA product code for Forceps, Biopsy, Electric, a class II device type, regulated under 21 CFR 876.4300. As of , FDA records hold 46 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- KGE
- Device name
- Forceps, Biopsy, Electric
- Regulation
- 21 CFR 876.4300
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 46
- Ingested recalls
- 0
Clearances, product code KGE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1991 | 3 |
| 1993 | 2 |
| 1994 | 4 |
| 1995 | 2 |
| 1996 | 2 |
| 1997 | 3 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2002 | 3 |
| 2006 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 3 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code KGE| Applicant | Clearances |
|---|---|
| Olympus Medical Systems Corp. | 4 |
| Boston Scientific Corporation | 4 |
| FUJIFILM Healthcare Americas Corporation | 3 |
| Micro-Tech (Nanjing) Co., Ltd. | 3 |
| Wilson-Cook Medical Inc. | 3 |
| Cox Medical Ent., Inc. | 2 |
| Horizons Intl. Corp. | 2 |
| OLYMPUS Corporation of the Americas | 2 |
| United States Endoscopy Group, Inc. | 2 |
| Apollo Endosurgery, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.