Cleared Traditional

K926127 - SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM

K926127 is an FDA 510(k) clearance for SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM, manufactured by Life Medical Sciences, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAG cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K926127 · Life Medical Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
202d
Days
Class 2
Risk

K926127 is an FDA 510(k) clearance for the SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Life Medical Sciences, Inc. (Arlington, US). The FDA issued a Cleared decision on June 24, 1993 after a review of 202 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 Life Medical Sciences, Inc. devices

FDA 510(k) Submission Details - K926127

510(k) Number K926127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1992
Decision Date June 24, 1993
Days to Decision 202 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 115d · This submission: 202d
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 K926127.
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
V. MUELLER (R) GOOSENECK CIRCULAR STAPLER
K862772 · American V. Mueller · Aug 1986
WECK LX TM SKIN STAPLER
K851258 · Edward Weck, Inc. · Jun 1985