BI-FLEX URETERAL ACCESS SHEATH— 510(k) K140441

Substantially Equivalent

Promepla Sam

FDA 510(k) clearance K140441 for BI-FLEX URETERAL ACCESS SHEATH, Substantially Equivalent on 2014-06-17. Applicant: Promepla Sam. Device class: 2.

Clearance details

Applicant: Promepla Sam
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2014-02-21
Decision date: 2014-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monaco, MC

Download summary PDF View on FDA.gov ↗

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K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE2014-06-16
K141252 — GUARDIAN URETHRAL SHEATH2014-06-09

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