Cleared Traditional

K934105 - DISPOS/REUSABLE SURG SKIN/STAINLESS STE...

K934105 is an FDA 510(k) clearance for DISPOS/REUSABLE SURG SKIN/STAINLESS STE..., manufactured by Surgical Innovations Corp.. The device is a Class 2 General & Plastic Surgery device with product code GAG cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K934105 · Surgical Innovations Corp. · General & Plastic Surgery device
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Mar 1994
Decision
217d
Days
Class 2
Risk

K934105 is an FDA 510(k) clearance for the DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Surgical Innovations Corp. (Claremont, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 217 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgical Innovations Corp. devices

FDA 510(k) Submission Details - K934105

510(k) Number K934105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1993
Decision Date March 28, 1994
Days to Decision 217 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 115d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAG Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (GAG) and FDA review panel - the closest regulatory comparables to K934105.
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
K213633 · Ethicon Endo-Surgery, LLC · Apr 2022
PROXIMATE DISPOSABLE SKIN STAPLER
K970079 · Ethicon Endo-Surgery, Inc. · Mar 1997
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
PROXIMATE LINEAR CUTTER THICK TISSUE INST.
K892927 · Ethicon, Inc. · May 1989