Cleared Traditional

K821228 - DEKNATEL SKIN STAPLE EXTRACTOR

K821228 is the FDA 510(k) clearance for DEKNATEL SKIN STAPLE EXTRACTOR by Howmedica Corp.. It is a Class 2 General & Plastic Surgery device (product code GAG) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K821228 · Howmedica Corp. · General & Plastic Surgery device
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May 1982
Decision
17d
Days
Class 2
Risk

K821228 is an FDA 510(k) clearance for the DEKNATEL SKIN STAPLE EXTRACTOR. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1982 after a review of 17 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 Howmedica Corp. devices

Submission Details

510(k) Number K821228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date May 14, 1982
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 29
Devices cleared under the same product code (GAG) and FDA review panel - the closest regulatory comparables to K821228.
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
APPOSE SKIN STAPLER
K811030 · Davis & Geck, Inc. · May 1981
PROXIMATE*II DISPOSABLE SKIN STAPLER
K803038 · Ethicon, Inc. · Dec 1980
SKIN STAPLER HANDLE 523700/CARTRIDGES
K801445 · Edward Weck, Inc. · Jul 1980