Cleared Traditional

K851258 - WECK LX TM SKIN STAPLER

K851258 is an FDA 510(k) clearance for WECK LX TM SKIN STAPLER, manufactured by Edward Weck, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAG cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K851258 · Edward Weck, Inc. · General & Plastic Surgery device
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Jun 1985
Decision
71d
Days
Class 2
Risk

K851258 is an FDA 510(k) clearance for the WECK LX TM SKIN STAPLER. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Edward Weck, Inc. (Research Triangle Pa, US). The FDA issued a Cleared decision on June 7, 1985 after a review of 71 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 Edward Weck, Inc. devices

FDA 510(k) Submission Details - K851258

510(k) Number K851258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1985
Decision Date June 07, 1985
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
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 32
Devices cleared under the same product code (GAG) and FDA review panel - the closest regulatory comparables to K851258.
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
V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS
K850947 · American V. Mueller · Apr 1985
APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE
K844417 · Davis & Geck, Inc. · Dec 1984
V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET
K844628 · American V. Mueller · Dec 1984