Cleared Traditional

K895591 - SILICONE INSTRUMENT SHODS

K895591 is an FDA 510(k) clearance for SILICONE INSTRUMENT SHODS, manufactured by Key Surgical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDJ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K895591 · Key Surgical, Inc. · General & Plastic Surgery device
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Oct 1989
Decision
35d
Days
Class 1
Risk

K895591 is an FDA 510(k) clearance for the SILICONE INSTRUMENT SHODS. Classified as Clamp, Surgical, General & Plastic Surgery (product code GDJ), Class I - General Controls.

Submitted by Key Surgical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 20, 1989 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Key Surgical, Inc. devices

FDA 510(k) Submission Details - K895591

510(k) Number K895591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1989
Decision Date October 20, 1989
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

GDJ Device Classification - Class 1, General Controls

Product Code GDJ Clamp, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.

Regulatory Peers - GDJ Clamp, Surgical, General & Plastic Surgery

All 19
Devices cleared under the same product code (GDJ) and FDA review panel - the closest regulatory comparables to K895591.
GS-7100 CHOLANGIOGRAM CLAMP, 5MM
K900956 · Solos Endoscopy, Inc. · Apr 1990
MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC
K901107 · United States Surgical, A Division of Tyco Healthc · Apr 1990
VESSEL OCCLUDER
K895726 · Applied Medical Technologies · Oct 1989
SURGICAL DUCT CLAMP (VINE)
K882169 · Henley Intl. · Jun 1988
AUTO SUTURE PURSE STRING APPLIER*
K874428 · United States Surgical, A Division of Tyco Healthc · Dec 1987
TOURIQUET KIT WITH SNARE
K855144 · Dlp, Inc. · Feb 1986