Cleared Traditional

K895682 - VESSEL LOOPS

K895682 is the FDA 510(k) clearance for VESSEL LOOPS by Applied Medical Technologies. It is a Class 1 General & Plastic Surgery device (product code GDX) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K895682 · Applied Medical Technologies · General & Plastic Surgery device
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Oct 1989
Decision
33d
Days
Class 1
Risk

K895682 is an FDA 510(k) clearance for the VESSEL LOOPS. Classified as Scalpel, One-piece (product code GDX), 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 33 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 K895682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1989
Decision Date October 24, 1989
Days to Decision 33 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
82d faster than avg
Panel avg: 115d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDX Scalpel, One-piece
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 - GDX Scalpel, One-piece

All 11
Devices cleared under the same product code (GDX) and FDA review panel - the closest regulatory comparables to K895682.
ICAN CYLINDRICAL SPONGES
K914086 · Icn Pharmaceuticals, Inc. · Oct 1991
CCI CORNEAL SCARIFIER
K904505 · Buckman Co., Inc. · Apr 1991
1-CUT ACL GRAFT KNIFE
K905380 · Depuy, Inc. · Dec 1990
7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1
K851751 · Artiberia · Jun 1985
H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48
K834541 · Imm Enterprises , Ltd. · Jan 1984
PILLING DIAMOND KNIFE
K822749 · Narco Scientific · Oct 1982