Cleared Traditional

K801154 - PROXIMATE*(ILS) DISP. INTRALUMINAL STAP.

K801154 is the FDA 510(k) clearance for PROXIMATE*(ILS) DISP. INTRALUMINAL STAP. by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K801154 · Ethicon, Inc. · General & Plastic Surgery device
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Jun 1980
Decision
37d
Days
Class 2
Risk

K801154 is an FDA 510(k) clearance for the PROXIMATE*(ILS) DISP. INTRALUMINAL STAP.. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1980 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - 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 K801154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1980
Decision Date June 20, 1980
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 - GDW Staple, Implantable

All 157
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K801154.
DISPOSABLE LINEAR STAPLER (LSF)
K822345 · Ethicon, Inc. · Sep 1982
DISPOSABLE LINEAR STAPLER-(LSR)
K821994 · Ethicon, Inc. · Aug 1982
AUTOMATIC HEMOCLIP APPLIER, 527700
K810324 · Edward Weck, Inc. · Mar 1981
AUTO SUTURE DISPOSABLE STAPLING INSTRU.
K780695 · United States Surgical, A Division of Tyco Healthc · Jun 1978
MICROCLIP, WILLIAMS
K780586 · Richard'S Medical Equip., Inc. · May 1978
DISP. LOADING UNIT, AUTO, SUTURE
K771178 · United States Surgical, A Division of Tyco Healthc · Oct 1977