SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET— 510(k) K001563

Name: FDA 510(k) clearance K001563
Creator: U.S. Food and Drug Administration
Published: 2000-11-22

Substantially Equivalent

Scion Cardiovascular, Inc.

FDA 510(k) clearance K001563 for SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET, Substantially Equivalent on 2000-11-22. Applicant: Scion Cardiovascular, Inc.. Device class: 2.

Clearance details

Applicant: Scion Cardiovascular, Inc.
Product code: Code FGO
Device class: Class 2
Regulation: 21 CFR 876.4680
Advisory panel: Gastroenterology, Urology
Date received: 2000-05-19
Decision date: 2000-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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K963750 — RETRIEVAL SNARE1996-11-22
K962676 — DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE1996-10-04
K951309 — STONE DISLODGER, BASKET1995-05-17
K933261 — GRASPING FORCEPS1994-01-11

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