GABRIS LAPAROSCOPIC SURGICAL KITS— 510(k) K944104

Name: FDA 510(k) clearance K944104
Creator: U.S. Food and Drug Administration
Published: 1994-09-13

Substantially Equivalent

Gabris Surgical Corp.

FDA 510(k) clearance K944104 for GABRIS LAPAROSCOPIC SURGICAL KITS, Substantially Equivalent on 1994-09-13. Applicant: Gabris Surgical Corp.. Device class: 2.

Clearance details

Applicant: Gabris Surgical Corp.
Product code: Code FBQ
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1994-08-23
Decision date: 1994-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Virginia Beach, VA, US

Download summary PDF View on FDA.gov ↗

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K944103 — LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT1994-09-12
K930716 — LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION1993-07-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.