MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT— 510(k) K010779

Name: FDA 510(k) clearance K010779
Creator: U.S. Food and Drug Administration
Published: 2001-04-10

Substantially Equivalent

Gibbons Surgical Corp.

FDA 510(k) clearance K010779 for MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT, Substantially Equivalent on 2001-04-10. Applicant: Gibbons Surgical Corp.. Device class: 2.

Clearance details

Applicant: Gibbons Surgical Corp.
Product code: Code FHO
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2001-03-15
Decision date: 2001-04-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Virginia Beach, VA, US

Download summary PDF View on FDA.gov ↗

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