Cleared Traditional

K803038 - PROXIMATE*II DISPOSABLE SKIN STAPLER

K803038 is the FDA 510(k) clearance for PROXIMATE*II DISPOSABLE 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 29-day FDA review.

K803038 · Ethicon, Inc. · General & Plastic Surgery device
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Dec 1980
Decision
29d
Days
Class 2
Risk

K803038 is an FDA 510(k) clearance for the PROXIMATE*II DISPOSABLE 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 December 30, 1980 after a review of 29 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 K803038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1980
Decision Date December 30, 1980
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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 K803038.
PROXIMATE DISPOSABLE SKIN STAPLERS
K820811 · Ethicon, Inc. · Aug 1982
DEKNATEL SKIN STAPLE EXTRACTOR
K821228 · Howmedica Corp. · May 1982
APPOSE SKIN STAPLER
K811030 · Davis & Geck, Inc. · May 1981
SKIN STAPLER HANDLE 523700/CARTRIDGES
K801445 · Edward Weck, Inc. · Jul 1980
PROXIMATE DISP. SKIN STAPLER
K771619 · Ethicon, Inc. · Nov 1977
SURGICAL STAPLING INSTRU., AUTO, SUTURE
K771177 · United States Surgical, A Division of Tyco Healthc · Oct 1977