Cleared Traditional

K812291 - ETHICON MULTIPLE LIGATING CLIP APPLIER

K812291 is the FDA 510(k) clearance for ETHICON MULTIPLE LIGATING CLIP APPLIER by Ethicon, Inc.. It is a Class 1 General & Plastic Surgery device (product code GDO) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K812291 · Ethicon, Inc. · General & Plastic Surgery device

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Sep 1981

Decision

29d

Days

Class 1

Risk

K812291 is an FDA 510(k) clearance for the ETHICON MULTIPLE LIGATING CLIP APPLIER. Classified as Applier, Surgical, Clip (product code GDO), Class I - General Controls.

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on September 11, 1981 after a review of 29 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 Ethicon, Inc. devices

Submission Details

510(k) Number	K812291 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 13, 1981
Decision Date	September 11, 1981
Days to Decision	29 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

86d faster than avg

Panel avg: 115d · This submission: 29d

Pathway characteristics

Predicate-based equivalence.

Device Classification

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 K812291.

MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP

K890941 · United States Surgical, A Division of Tyco Healthc · Apr 1989

SUTURE CLIP APPLIER/REMOVER

K890233 · Kinetic Medical Products · Jan 1989

DISPOSABLE MULTIPLE LIGATING CLIP

K820837 · Ethicon, Inc. · May 1982

HEMOSPENSER CARTRIDGE CAT. NO. 523500-

K792378 · Edward Weck, Inc. · Dec 1979

BAYONET HEIFETZ CLIP APPLIERS

K791845 · Edward Weck, Inc. · Oct 1979

360 HEMOCLIP APPLIERS

K791157 · Edward Weck, Inc. · Jun 1979

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K812291

Ethicon, Inc.

Walker, MI · US

Regulatory profile

205 submissions 198 cleared

97% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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