URETHRAL DILATOR ENDOSCOPE— 510(k) K874530

Name: FDA 510(k) clearance K874530
Creator: U.S. Food and Drug Administration
Published: 1988-01-27

Substantially Equivalent

Advanced Surgical Intervention, Inc.

FDA 510(k) clearance K874530 for URETHRAL DILATOR ENDOSCOPE, Substantially Equivalent on 1988-01-27. Applicant: Advanced Surgical Intervention, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Surgical Intervention, Inc.
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1987-11-03
Decision date: 1988-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

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