Fujifilm Diathermic Slitter (FlushKnife)— 510(k) K171096
Substantially EquivalentFujifilm Medical Systems U.S.A, Inc.
FDA 510(k) clearance K171096 for Fujifilm Diathermic Slitter (FlushKnife), Substantially Equivalent on 2017-05-09. 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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