Wiltek Hot Biopsy Forceps
FDA 510(k) K990231 · Wiltek Medical, Inc.
510(k) numberK990231
Submission
- Device name
- Wiltek Hot Biopsy Forceps
- Applicant
- Wiltek Medical, Inc.
Winston-Salem, NC, US - Received
- January 25, 1999
- Decision date
- April 13, 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 |
|---|---|---|
| K922989 | Wiltek Irrigaiton/Aspiration Tube SetBYY · Traditional | 02/15/1994SE |
| K930419 | Wiltek Biopsy ForcepsBWH · Traditional | 06/01/1993SE |
| K914882 | Wiltek Balloon Cholangiography CatheterFGE · Traditional | 01/07/1992SE |
| K914881 | Wiltek Laparoscopic Cholangiography CatheterFGE · Traditional | 01/07/1992SE |
| K914132 | Wiltek Electrocautery Active CordGEI · Traditional | 09/25/1991SE |
| K914131 | Wiltek Electrocautery AdaptorGEI · Traditional | 09/25/1991SE |
| K912288 | Wiltek Standard Cholangiography CatheterFGE · Traditional | 09/23/1991SE |
| K912122 | Cholangiography CatheterFGE · Traditional | 09/23/1991SE |
| K910334 | Electrocautery ProbeGEI · Traditional | 02/21/1991SE |
| K894871 | Wiltek Biliary Stent SetFGE · Traditional | 12/21/1989SE |
Questions and answers
When was Wiltek Hot Biopsy Forceps cleared by the FDA?
Wiltek Hot Biopsy Forceps (K990231) received a 510(k) decision of Substantially Equivalent on April 13, 1999, 78 days after the submission was received.
What is the product code of K990231?
The FDA product code is KGE – Forceps, Biopsy, Electric, a Class II (moderate risk) device regulated under 21 CFR 876.4300.