Cleared Traditional

K920847 - ETHICON LIGACLIP ENDO LD APPLIER/DIVIDER

K920847 is the FDA 510(k) clearance for ETHICON LIGACLIP ENDO LD APPLIER/DIVIDER by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K920847 · Ethicon, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 1992
Decision
94d
Days
Class 2
Risk

K920847 is an FDA 510(k) clearance for the ETHICON LIGACLIP ENDO LD APPLIER/DIVIDER. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Ethicon, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 29, 1992 after a review of 94 days - within the typical 510(k) review window.

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: 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 K920847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1992
Decision Date May 29, 1992
Days to Decision 94 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
21d faster than avg
Panel avg: 115d · This submission: 94d
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 96
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K920847.
IMPLANTABLE CLIP APPLIER
K934087 · United States Surgical, A Division of Tyco Healthc · Dec 1993
IMPLANTABLE CLIP
K933887 · United States Surgical, A Division of Tyco Healthc · Nov 1993
LAPRA-TY* SUTURE CLIP
K931492 · Ethicon, Inc. · Aug 1993
AUTO SUTURE MODIFIED POLYMER SKIN GRAFT STAPLE
K915151 · United States Surgical, A Division of Tyco Healthc · Jan 1992
HEMOCLIP II
K911915 · Edward Weck, Inc. · Jan 1992
AUTO SUTURE(R) ENDOSCOPIC LDS(TM) LIGATING DEVICE
K905587 · United States Surgical, A Division of Tyco Healthc · Jan 1991