Cleared Traditional

K902682 - STICK-GARD STERILE CAP

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

FDA 510(k) Submission Details - K902682

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
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 36
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K902682.
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OLYMPIC WARMETTE
K911955 · Olympic Medical Corp. · Jul 1991
GLOVE LEAK DETECTOR
K901237 · Utah Medical Products, Inc. · Aug 1990
SARNS MEDICAL CART
K892052 · 3M Company · Jun 1989
BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE
K874186 · Busse Hospital Disposables, Inc. · Dec 1987