Cleared Traditional

K970079 - PROXIMATE DISPOSABLE SKIN STAPLER

K970079 is the FDA 510(k) clearance for PROXIMATE DISPOSABLE SKIN STAPLER by Ethicon Endo-Surgery, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAG) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K970079 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
61d
Days
Class 2
Risk

K970079 is an FDA 510(k) clearance for the PROXIMATE DISPOSABLE SKIN STAPLER. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 11, 1997 after a review of 61 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 Endo-Surgery, Inc. devices

Submission Details

510(k) Number K970079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1997
Decision Date March 11, 1997
Days to Decision 61 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
54d faster than avg
Panel avg: 115d · This submission: 61d
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 24
Devices cleared under the same product code (GAG) and FDA review panel - the closest regulatory comparables to K970079.
EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil
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ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
K213633 · Ethicon Endo-Surgery, LLC · Apr 2022
ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP
K962258 · Ethicon Endo-Surgery, Inc. · Sep 1996
DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART
K934188 · Deroyal Industries, Inc. · Mar 1994
PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER
K932476 · Ethicon Endo-Surgery, Inc. · Dec 1993