Cleared Traditional

K902682 - STICK-GARD STERILE CAP (FDA 510(k) Clearance)

K902682 · Integrated Medical Systems, Inc. · General & Plastic Surgery device
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Sep 1990
Decision
99d
Days
-
Risk

K902682 is an FDA 510(k) clearance for the STICK-GARD STERILE CAP.

Submitted by Integrated Medical Systems, Inc. (South El Monte, US). The FDA issued a Cleared decision on September 26, 1990 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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. Standard predicate reliance. 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.

View all Integrated Medical Systems, Inc. devices

Submission Details

510(k) Number K902682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1990
Decision Date September 26, 1990
Days to Decision 99 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 114d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -