Cleared Traditional

K780286 - BRACHIAL-LARGE VESSEL APPROXIMATOR

K780286 is an FDA 510(k) clearance for BRACHIAL-LARGE VESSEL APPROXIMATOR, manufactured by Edward Weck, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDJ cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K780286 · Edward Weck, Inc. · General & Plastic Surgery device
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Feb 1978
Decision
7d
Days
Class 1
Risk

K780286 is an FDA 510(k) clearance for the BRACHIAL-LARGE VESSEL APPROXIMATOR. Classified as Clamp, Surgical, General & Plastic Surgery (product code GDJ), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1978 after a review of 7 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 Edward Weck, Inc. devices

FDA 510(k) Submission Details - K780286

510(k) Number K780286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1978
Decision Date February 28, 1978
Days to Decision 7 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
108d faster than avg
Panel avg: 115d · This submission: 7d
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 15
Devices cleared under the same product code (GDJ) and FDA review panel - the closest regulatory comparables to K780286.
VESSEL OCCLUDER
K800074 · Cordis Corp. · Jan 1980
CONPHAR UMBILICAL CORD CLAMP
K791800 · Conphar, Inc. · Sep 1979
CONPHAR TUBE CLAMPS
K791802 · Conphar, Inc. · Sep 1979
BRACHEAL-LARGE VESSEL CLIP
K780288 · Edward Weck, Inc. · Feb 1978
ULNAR-RADIAL CLIP
K780290 · Edward Weck, Inc. · Feb 1978
ULNAR-RADIAL APPROXIMATER
K780291 · Edward Weck, Inc. · Feb 1978