Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
FDA 510(k) K151474 · Fujifilm Medical System U.S.A., Inc.
510(k) numberK151474
Submission
- Device name
- Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
- Applicant
- Fujifilm Medical System U.S.A., Inc.
Wayne, NJ, US - Received
- June 1, 2015
- Decision date
- February 18, 2016
- 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
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|---|---|---|---|
| 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 |
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Questions and answers
When was Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) cleared by the FDA?
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) (K151474) received a 510(k) decision of Substantially Equivalent on February 18, 2016, 262 days after the submission was received.
What is the product code of K151474?
The FDA product code is KGE – Forceps, Biopsy, Electric, a Class II (moderate risk) device regulated under 21 CFR 876.4300.