Cleared Traditional

K792378 - HEMOSPENSER CARTRIDGE CAT. NO. 523500-

K792378 is an FDA 510(k) clearance for HEMOSPENSER CARTRIDGE CAT. NO. 523500-, manufactured by Edward Weck, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDO cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K792378 · Edward Weck, Inc. · General & Plastic Surgery device
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Dec 1979
Decision
10d
Days
Class 1
Risk

K792378 is an FDA 510(k) clearance for the HEMOSPENSER CARTRIDGE CAT. NO. 523500-. Classified as Applier, Surgical, Clip (product code GDO), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979 after a review of 10 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 - K792378

510(k) Number K792378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1979
Decision Date December 06, 1979
Days to Decision 10 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
105d faster than avg
Panel avg: 115d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

GDO Device Classification - Class 1, General Controls

Product Code GDO Applier, Surgical, Clip
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 - GDO Applier, Surgical, Clip

All 9
Devices cleared under the same product code (GDO) and FDA review panel - the closest regulatory comparables to K792378.
SUTURE CLIP APPLIER/REMOVER
K890233 · Kinetic Medical Products · Jan 1989
DISPOSABLE MULTIPLE LIGATING CLIP
K820837 · Ethicon, Inc. · May 1982
ETHICON MULTIPLE LIGATING CLIP APPLIER
K812291 · Ethicon, Inc. · Sep 1981
BAYONET HEIFETZ CLIP APPLIERS
K791845 · Edward Weck, Inc. · Oct 1979
360 HEMOCLIP APPLIERS
K791157 · Edward Weck, Inc. · Jun 1979
REYNOLDS DOUBLE HEMOCLIP APPLIERS
K790990 · Edward Weck, Inc. · Jun 1979