Cleared Traditional

STRYKER ENDOSCOPY CHOLANGIOGRAM KIT

K924212 · Stryker Corp. · General & Plastic Surgery
Jul 1993
Decision
321d
Days
Class 1
Risk

About This 510(k) Submission

K924212 is an FDA 510(k) clearance for the STRYKER ENDOSCOPY CHOLANGIOGRAM KIT, a Catheter, Cholangiography (Class I — General Controls, product code GBZ), submitted by Stryker Corp. (San Jose, US). The FDA issued a Cleared decision on July 7, 1993, 321 days after receiving the submission on August 20, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number K924212 FDA.gov
FDA Decision Cleared SESK
Date Received August 20, 1992
Decision Date July 07, 1993
Days to Decision 321 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GBZ — Catheter, Cholangiography
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4200

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