Cleared Traditional

K934174 - LIGACLIP ENDOSCOPIC ROTATING MULTIPLE C...

K934174 is the FDA 510(k) clearance for LIGACLIP ENDOSCOPIC ROTATING MULTIPLE C... by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code OCW) cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K934174 · Ethicon, Inc. · General & Plastic Surgery device
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Mar 1994
Decision
194d
Days
Class 2
Risk

K934174 is an FDA 510(k) clearance for the LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Ethicon, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 9, 1994 after a review of 194 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K934174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1993
Decision Date March 09, 1994
Days to Decision 194 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 115d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCW Endoscopic Tissue Approximation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
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 - OCW Endoscopic Tissue Approximation Device

All 36
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K934174.
MODIFIED ENDOPATH ILS
K940967 · Ethicon Endo-Surgery, Inc. · May 1994
ENDOSCOPIC ARTICULATING MULTI-FEED STAPLER WITH RELOAD UNIT
K935756 · Ethicon Endo-Surgery, Inc. · Apr 1994
AUTOSUTURE ENDOSCOPIC SUTURING DEVICE
K934738 · United States Surgical, A Division of Tyco Healthc · Mar 1994
PROXIMATE ARTICULATING LINEAR STAPLER
K932434 · Ethicon Endo-Surgery, Inc. · Feb 1994
ENDOPATH ENDOSCOPIC LINEAR CUTTER MODIFICATION
K935064 · Ethicon, Inc. · Jan 1994