Bipolar Biopsy Forceps
FDA 510(k) K904985 · Everest Medical Corp.
510(k) numberK904985
Submission
- Device name
- Bipolar Biopsy Forceps
- Applicant
- Everest Medical Corp.
Minneapolis, MN, US - Received
- November 2, 1990
- Decision date
- January 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KGE – Forceps, Biopsy, Electric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KGE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LRKGE · Traditional | Olympus Medical Systems Corp. | 03/06/2026SE |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)KGE · Traditional | Olympus Medical Systems Corporation | 10/07/2025SE |
| K242857 | ClearHemograsperKGE · Traditional | Finemedix Co., Ltd. | 05/21/2025SE |
| K231721 | Disposable Hot Biopsy ForcepsKGE · Traditional | Beijing Zksk Technology Co., Ltd. | 12/14/2023SE |
| K220053 | Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIKGE · Special | Fujifilm Corporation | 02/04/2022SE |
| K210406 | Bipolar Coagulation ForecepsKGE · Traditional | Hangzhou AGS MedTech Co., Ltd. | 10/05/2021SE |
| K202438 | Ensure Single-Use Coagulation ForcepsKGE · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 03/15/2021SE |
| K183428 | Avulsion ForcepsKGE · Traditional | STERIS Corporation | 04/16/2019SE |
| K180018 | Disposable Hot Biopsy ForcepsKGE · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 07/05/2018SE |
| K180134 | Ensizor Monopolar Endoscopic ScissorsKGE · Traditional | Slater Endoscopy, LLC | 06/29/2018SE |
More from Slater Endoscopy, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K003060 | Plasmakinetic GeneratorGEI · Special | 10/31/2000SE |
| K000496 | Evershears Bipolar ScissorsGEI · Traditional | 04/24/2000SE |
| K993412 | Bitx ProbesGEI · Traditional | 03/31/2000SE |
| K994336 | Bitx ProbesGEI · Traditional | 02/08/2000SE |
| K971565 | Bicoag Coagulating ForcepsHIN · Traditional | 03/12/1998SE |
| K955001 | Evershears Scissors, Bilap Probes, Bicoag ForcepsGEI · Traditional | 12/13/1995SE |
| K945975 | Evershears(R) Scissors, Bilap(R) Probes, Bicoag(R) ForcepsGEI · Traditional | 12/21/1994SE |
| K922509 | Laparoscopic Electrosurg Device W/Irriga & AspiraGEI · Traditional | 10/01/1992SE |
| K922246 | Tubing Set W/ Irrigation & Aspiration ValvingGCJ · Traditional | 09/02/1992SE |
| K920089 | Monopolar Coagulating Polypectomy SnareKNS · Traditional | 03/31/1992SE |
Questions and answers
When was Bipolar Biopsy Forceps cleared by the FDA?
Bipolar Biopsy Forceps (K904985) received a 510(k) decision of Substantially Equivalent on January 25, 1991, 84 days after the submission was received.
What is the product code of K904985?
The FDA product code is KGE – Forceps, Biopsy, Electric, a Class II (moderate risk) device regulated under 21 CFR 876.4300.