Cleared Traditional

MULTICLIP DISP. LIGATING CLIP DEVICE (K820999) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K820999 · Davis & Geck, Inc. · General & Plastic Surgery device
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May 1982
Decision
35d
Days
Class 2
Risk

K820999 is an FDA 510(k) clearance for the MULTICLIP DISP. LIGATING CLIP DEVICE. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Davis & Geck, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1982 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 878.4300 - 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 Davis & Geck, Inc. devices

Submission Details

510(k) Number K820999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1982
Decision Date May 13, 1982
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. No clinical trials required.

Device Classification

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FZP Clip, Implantable

All 64
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K820999.
LIGACLIP METALLIC LIGATING CLIP
K834267 · Ethicon, Inc. · Mar 1984
AUTO SUTURE POLY SURGICLIP HEMOSTATIC
K831457 · United States Surgical, A Division of Tyco Healthc · Aug 1983
LIGACLIP TITANIUM LIGATING CLIP
K830503 · Ethicon, Inc. · Mar 1983
PDS* ABSORBABLE LIGATING CLIPS
K812323 · Ethicon, Inc. · Nov 1981
PROLENE POLYPROPYLENE LIGATING CLIP
K811935 · Ethicon, Inc. · Sep 1981
NYLON LIGATING CLIP
K801124 · Ethicon, Inc. · Jun 1980