Cleared Traditional

K895726 - VESSEL OCCLUDER

K895726 is the FDA 510(k) clearance for VESSEL OCCLUDER by Applied Medical Technologies. It is a Class 1 General & Plastic Surgery device (product code GDJ) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K895726 · Applied Medical Technologies · General & Plastic Surgery device
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Oct 1989
Decision
29d
Days
Class 1
Risk

K895726 is an FDA 510(k) clearance for the VESSEL OCCLUDER. Classified as Clamp, Surgical, General & Plastic Surgery (product code GDJ), Class I - General Controls.

Submitted by Applied Medical Technologies (Independence, US). The FDA issued a Cleared decision on October 24, 1989 after a review of 29 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 Applied Medical Technologies devices

Submission Details

510(k) Number K895726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1989
Decision Date October 24, 1989
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 16
Devices cleared under the same product code (GDJ) and FDA review panel - the closest regulatory comparables to K895726.
THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE
K930315 · Thomasville Medical Assoc. · Feb 1994
MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC
K901107 · United States Surgical, A Division of Tyco Healthc · Apr 1990
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
BACKHAUS TOWEL CLAMP, 5-1/2 + SS 410 OR 420
K852724 · The Huxley Instrument Corp. · Jul 1985