Cleared Traditional

HEMOCLIP SURGICAL OCCLUDING CLIP (K800079) - FDA 510(k) Clearance

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

K800079 · Edward Weck, Inc. · General & Plastic Surgery device
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Jan 1980
Decision
14d
Days
Class 2
Risk

K800079 is an FDA 510(k) clearance for the HEMOCLIP SURGICAL OCCLUDING CLIP. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1980 after a review of 14 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 Edward Weck, Inc. devices

Submission Details

510(k) Number K800079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1980
Decision Date January 28, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
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 63
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K800079.
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
LIGACLIP MULTIPLE LIGATING CLIPS
K771413 · Ethicon, Inc. · Nov 1977
AUTO SUTURE R CLIP
K771112 · United States Surgical, A Division of Tyco Healthc · Sep 1977