FDA product code KGE: Forceps, Biopsy, Electric
KGE is the FDA product code for forceps, biopsy, electric. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 46 510(k) submissions under KGE, 5 in the last five years, from 34 different applicants. The average 510(k) review took 141 days (median 120); 258 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Biopsy, Electric |
| Device class | Class II |
| Regulation | 21 CFR 876.4300 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KGE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 68 |
| 2018 | 3 | 204 |
| 2019 | 1 | 126 |
| 2021 | 2 | 220 |
| 2022 | 1 | 29 |
| 2023 | 1 | 184 |
| 2025 | 2 | 250 |
| 2026 | 1 | 267 |
Compare with all 510(k) review times · Search every KGE clearance
Top KGE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | 3 | 2021-03-15 |
| Wilson-Cook Medical, Inc. | 3 | 2018-03-21 |
| Olympus Medical Systems Corp. | 2 | 2026-03-06 |
| Olympus Medical Systems Corporation | 2 | 2025-10-07 |
| Fujifilm Medical Systems U.S.A, Inc. | 2 | 2017-05-09 |
29 more applicants have KGE clearances. See the full list in Caduvo.
Most recent KGE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251807 | Olympus Medical Systems Corp. | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | 2026-03-06 | 267 |
| K250187 | Olympus Medical Systems Corporation | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | 2025-10-07 | 258 |
| K242857 | Finemedix Co., Ltd. | ClearHemograsper | 2025-05-21 | 243 |
| K231721 | Beijing Zksk Technology Co., Ltd. | Disposable Hot Biopsy Forceps | 2023-12-14 | 184 |
| K220053 | Fujifilm Corporation | Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI | 2022-02-04 | 29 |
Recalls for KGE devices
openFDA lists no recalls for product code KGE.
Frequently asked questions
What is FDA product code KGE?
KGE is the FDA product code for forceps, biopsy, electric. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.
What device class is KGE?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code KGE?
Across 46 cleared submissions the average was 141 days from receipt to decision (median 120).
Which companies have the most KGE clearances?
Micro-Tech (Nanjing) Co., Ltd. (3); Wilson-Cook Medical, Inc. (3); Olympus Medical Systems Corp. (2); Olympus Medical Systems Corporation (2); Fujifilm Medical Systems U.S.A, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code KGE
- Run a recall and safety report across every KGE manufacturer
- Watch product code KGE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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