KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA— 510(k) K120898

Name: FDA 510(k) clearance K120898
Creator: U.S. Food and Drug Administration
Published: 2012-08-03

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K120898 for KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA, Substantially Equivalent on 2012-08-03. Applicant: Richard Wolf Medical Instruments Corp.. Device class: 2.

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code OTJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2012-03-26
Decision date: 2012-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

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