Cleared Traditional

K844417 - APPOSE ULTRA DISPOS. SKIN STAPLER W/AUT...

K844417 is an FDA 510(k) clearance for APPOSE ULTRA DISPOS. SKIN STAPLER W/AUT..., 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 32-day FDA review.

K844417 · Davis & Geck, Inc. · General & Plastic Surgery device
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Dec 1984
Decision
32d
Days
Class 2
Risk

K844417 is an FDA 510(k) clearance for the APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Davis & Geck, Inc. (Danbury, US). The FDA issued a Cleared decision on December 17, 1984 after a review of 32 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 - K844417

510(k) Number K844417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1984
Decision Date December 17, 1984
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
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 K844417.
V. MUELLER (R) GOOSENECK CIRCULAR STAPLER
K862772 · American V. Mueller · Aug 1986
WECK LX TM SKIN STAPLER
K851258 · Edward Weck, Inc. · Jun 1985
V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS
K850947 · American V. Mueller · Apr 1985
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