Cleared Traditional

K051950 - INSCOPE MULTI-CLIP APPLIER

K051950 is the FDA 510(k) clearance for INSCOPE MULTI-CLIP APPLIER by Ethicon Endo-Surgery, Inc.. It is a Class 2 General & Plastic Surgery device (product code MND) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K051950 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
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Oct 2005
Decision
81d
Days
Class 2
Risk

K051950 is an FDA 510(k) clearance for the INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321. Classified as Ligator, Esophageal (product code MND), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 7, 2005 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.4400 - 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 Endo-Surgery, Inc. devices

Submission Details

510(k) Number K051950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2005
Decision Date October 07, 2005
Days to Decision 81 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
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MND Ligator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4400
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 - MND Ligator, Esophageal

All 9
Devices cleared under the same product code (MND) and FDA review panel - the closest regulatory comparables to K051950.
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K033245 · C.R. Bard, Inc. · Nov 2003
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K022434 · C.R. Bard, Inc. · Aug 2002
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K013066 · Olympus America, Inc. · Dec 2001
OLYMPUS ENDOSCOPIC LIGATION DEVICE
K001744 · Olympus America, Inc. · Feb 2001
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K990864 · Boston Scientific Corp · Jun 1999
HX-20/21-1 ENDOSCOPIC LIGATOR
K964661 · Olympus America, Inc. · Oct 1997