Cleared Traditional

K830741 - PARAMETRIC STERILITY RELEASE OF AUTO

K830741 is an FDA 510(k) clearance for PARAMETRIC STERILITY RELEASE OF AUTO, manufactured by United Surgical Corp.. The device is a Class 2 General & Plastic Surgery device with product code GAG cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K830741 · United Surgical Corp. · General & Plastic Surgery device
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Aug 1983
Decision
156d
Days
Class 2
Risk

K830741 is an FDA 510(k) clearance for the PARAMETRIC STERILITY RELEASE OF AUTO. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by United Surgical Corp. (Walker, US). The FDA issued a Cleared decision on August 11, 1983 after a review of 156 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 United Surgical Corp. devices

FDA 510(k) Submission Details - K830741

510(k) Number K830741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1983
Decision Date August 11, 1983
Days to Decision 156 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 115d · This submission: 156d
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 K830741.
V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET
K844628 · American V. Mueller · Dec 1984
APPOSE ULE STERILE DISPOS. SKIN STAP
K840177 · Davis & Geck, Inc. · Mar 1984
APPOSE DISPOS. SKIN STAPLER W/AUTO
K840178 · Davis & Geck, Inc. · Mar 1984
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