Cleared Traditional

K924212 - STRYKER ENDOSCOPY CHOLANGIOGRAM KIT (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

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

K924212 is an FDA 510(k) clearance for the STRYKER ENDOSCOPY CHOLANGIOGRAM KIT. Classified as Catheter, Cholangiography (product code GBZ), Class I - General Controls.

Submitted by Stryker Corp. (San Jose, US). The FDA issued a Cleared decision on July 7, 1993 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K924212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 114d · This submission: 321d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBZ Catheter, Cholangiography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.