Cleared Traditional

K840177 - APPOSE ULE STERILE DISPOS. SKIN STAP

K840177 is an FDA 510(k) clearance for APPOSE ULE STERILE DISPOS. SKIN STAP, manufactured by Davis & Geck, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAG cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K840177 · Davis & Geck, Inc. · General & Plastic Surgery device
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Mar 1984
Decision
48d
Days
Class 2
Risk

K840177 is an FDA 510(k) clearance for the APPOSE ULE STERILE DISPOS. SKIN STAP. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Davis & Geck, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984 after a review of 48 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 Davis & Geck, Inc. devices

FDA 510(k) Submission Details - K840177

510(k) Number K840177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1984
Decision Date March 05, 1984
Days to Decision 48 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
67d faster than avg
Panel avg: 115d · This submission: 48d
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 K840177.
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
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