Cleared Traditional

K771619 - PROXIMATE DISP. SKIN STAPLER

K771619 is the FDA 510(k) clearance for PROXIMATE DISP. SKIN STAPLER by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAG) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K771619 · Ethicon, Inc. · General & Plastic Surgery device
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Nov 1977
Decision
83d
Days
Class 2
Risk

K771619 is an FDA 510(k) clearance for the PROXIMATE DISP. SKIN STAPLER. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1977 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4740 - 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 K771619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1977
Decision Date November 15, 1977
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAG Stapler, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4740
Definition A Surgical Stapler For Internal Use Is A Specialized Prescription Device Used To Deliver Compatible Staples To Internal Tissues During Surgery For Resection, Transection, And Creating Anastomoses.
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 - GAG Stapler, Surgical

All 29
Devices cleared under the same product code (GAG) and FDA review panel - the closest regulatory comparables to K771619.
APPOSE SKIN STAPLER
K811030 · Davis & Geck, Inc. · May 1981
PROXIMATE*II DISPOSABLE SKIN STAPLER
K803038 · Ethicon, Inc. · Dec 1980
SKIN STAPLER HANDLE 523700/CARTRIDGES
K801445 · Edward Weck, Inc. · Jul 1980
SURGICAL STAPLING INSTRU., AUTO, SUTURE
K771177 · United States Surgical, A Division of Tyco Healthc · Oct 1977
AUTO SUTURE R CLIP INSTRUMENT
K771113 · United States Surgical, A Division of Tyco Healthc · Sep 1977
SKIN STAPLING INSTRUMENT
K760732 · Ethicon, Inc. · Nov 1976