SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM— 510(k) K120127

Name: FDA 510(k) clearance K120127
Creator: U.S. Food and Drug Administration
Published: 2012-10-26

Substantially Equivalent

Swan Valley Medical, Incorporated

FDA 510(k) clearance K120127 for SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM, Substantially Equivalent on 2012-10-26. Applicant: Swan Valley Medical, Incorporated. Device class: 2.

Clearance details

Applicant: Swan Valley Medical, Incorporated
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 2012-01-17
Decision date: 2012-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

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