Cleared Traditional

K821024 - DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K821024 · Howmedica Corp. · General & Plastic Surgery device
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May 1982
Decision
31d
Days
Class 1
Risk

K821024 is an FDA 510(k) clearance for the DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE. Classified as Staple, Removable (skin) (product code GDT), Class I - General Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1982 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4760 - 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 K821024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1982
Decision Date May 14, 1982
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 114d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDT Staple, Removable (skin)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.