Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)— 510(k) K161186
Substantially EquivalentFujifilm Medical Systems U.S.A, Inc.
FDA 510(k) clearance K161186 for Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter), Substantially Equivalent on 2016-06-29. Applicant: Fujifilm Medical Systems U.S.A, Inc.. Device class: 2.
Clearance details
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- Product code
- Code KGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Wayne, NJ, US
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More clearances from Fujifilm Medical Systems U.S.A, Inc.
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