Multi-Bite Hot Biopsy Forceps
FDA 510(k) K090796 · Endo-Therapeutics, Inc.
510(k) numberK090796
Submission
- Device name
- Multi-Bite Hot Biopsy Forceps
- Applicant
- Endo-Therapeutics, Inc.
Clearwater, FL, US - Received
- March 24, 2009
- Decision date
- November 25, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K031026 | Eti Bipolar Hemostatic ProbeKNS · Traditional | 06/27/2003SE |
| K023603 | Endo-Glide GuidewireOCY · Traditional | 02/19/2003SE |
| K012725 | Tissue Grasping Forceps, Scissors, Clamps and Dissectors for Laparoscopic SurgeriesGEI · Traditional | 11/08/2001SE |
| K012977 | Varices Injection NeedleFBK · Traditional | 11/02/2001SE |
| K926549 | Endocath Electrophysiology CatheterDRF · Traditional | 12/06/1993SE |
| K925392 | Biopsy ForcepsFCL · Traditional | 11/05/1993SE |
Questions and answers
When was Multi-Bite Hot Biopsy Forceps cleared by the FDA?
Multi-Bite Hot Biopsy Forceps (K090796) received a 510(k) decision of Substantially Equivalent on November 25, 2009, 246 days after the submission was received.
What is the product code of K090796?
The FDA product code is KGE – Forceps, Biopsy, Electric, a Class II (moderate risk) device regulated under 21 CFR 876.4300.