Disposable Hot Biopsy Forceps
FDA 510(k) K180018 · Micro-Tech (Nanjing) Co., Ltd.
510(k) numberK180018
Submission
- Device name
- Disposable Hot Biopsy Forceps
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
Nanjing, CN - Received
- January 2, 2018
- Decision date
- July 5, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K180134 | Ensizor Monopolar Endoscopic ScissorsKGE · Traditional | Slater Endoscopy, LLC | 06/29/2018SE |
| K171973 | Captura® Disposable Hot Biopsy ForcepsKGE · Traditional | Wilson-Cook Medical, Inc. | 03/21/2018SE |
More from Wilson-Cook Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252492 | Visualized Access and Delivery Catheter; PB Digital ControllerSHU · Traditional | 04/24/2026SE |
| K251692 | Advanced Tissue Resection DeviceFDI · Traditional | 02/21/2026SE |
| K250229 | Dual Action Tissue Closure DevicePKL · Traditional | 09/08/2025SE |
| K243388 | Disposable Distal CapFDS · Traditional | 06/27/2025SE |
| K243471 | Extraction BasketLQR · Traditional | 12/16/2024SE |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set…FGE · Traditional | 09/06/2023SE |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital ControllerFBN · Traditional | 02/16/2023SE |
| K222354 | Elastic Traction SystemQSW · Traditional | 10/03/2022SE |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…KTI · Traditional | 07/20/2022SE |
| K220424 | Through the Scope Tracheal Stent SystemJCT · Traditional | 07/08/2022SE |
Questions and answers
When was Disposable Hot Biopsy Forceps cleared by the FDA?
Disposable Hot Biopsy Forceps (K180018) received a 510(k) decision of Substantially Equivalent on July 5, 2018, 184 days after the submission was received.
What is the product code of K180018?
The FDA product code is KGE – Forceps, Biopsy, Electric, a Class II (moderate risk) device regulated under 21 CFR 876.4300.