Hot Biopsy Forceps Feenestrated 230 CM Oval Cup, Hot Biopsy Forceps Serrated 160 CM Oval Cup, Hot Biopsy Forceps Serratd
FDA 510(k) K992390 · Telemed Systems, Inc.
510(k) numberK992390
Submission
- Device name
- Hot Biopsy Forceps Feenestrated 230 CM Oval Cup, Hot Biopsy Forceps Serrated 160 CM Oval Cup, Hot Biopsy Forceps Serratd
- Applicant
- Telemed Systems, Inc.
Marlborough, MA, US - Received
- July 19, 1999
- Decision date
- December 22, 1999
- 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 |
|---|---|---|
| K020379 | PPD Balloon Dilatation CatheterKNT · Special | 05/06/2002SE |
| K013737 | Modification to: 3-LUMEN Duralon Occlusion BalloonFGE · Special | 03/01/2002SE |
| K010412 | Flexible Endoscopic ScissorsOCZ · Traditional | 04/02/2001SE |
| K992402 | 5.0 French X 200CM X 35MM Tip TAPER-20MM Cutting Wire, 5.0 French X 200CM X 35MM Tip…KNS · Traditional | 12/22/1999SE |
| K974312 | Reusable Biopsy Forceps Oval Cup, Reusable Biosy Forceps Oval Cup W/Needle, Reusable…KNW · Traditional | 01/21/1998SE |
| K974300 | Telemed Systems Retrieval BasketOCZ · Traditional | 12/19/1997SE |
| K901435 | Gastrointestinal Cytology BrushFDX · Traditional | 07/16/1990SE |
| K901427 | Biliary Stone Retrieval and Occlusion BalloonFGE · Traditional | 06/22/1990SE |
| K901433 | Sure-Flex Anastomotic Balloon DilatorFGE · Traditional | 06/21/1990SE |
| K901432 | Biliary Balloon DilatorFGE · Traditional | 06/21/1990SE |
Questions and answers
When was Hot Biopsy Forceps Feenestrated 230 CM Oval Cup, Hot Biopsy Forceps Serrated 160 CM Oval Cup, Hot Biopsy Forceps Serratd cleared by the FDA?
Hot Biopsy Forceps Feenestrated 230 CM Oval Cup, Hot Biopsy Forceps Serrated 160 CM Oval Cup, Hot Biopsy Forceps Serratd (K992390) received a 510(k) decision of Substantially Equivalent on December 22, 1999, 156 days after the submission was received.
What is the product code of K992390?
The FDA product code is KGE – Forceps, Biopsy, Electric, a Class II (moderate risk) device regulated under 21 CFR 876.4300.