Cleared Traditional

K822963 - SURGICAL PRODUCTS, SKIN STAPLE REMOVER

K822963 is an FDA 510(k) clearance for SURGICAL PRODUCTS, manufactured by Temp-Stik Corp.. The device is a Class 1 General & Plastic Surgery device with product code FZQ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K822963 · Temp-Stik Corp. · General & Plastic Surgery device
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Nov 1982
Decision
34d
Days
Class 1
Risk

K822963 is an FDA 510(k) clearance for the SURGICAL PRODUCTS, SKIN STAPLE REMOVER. Classified as Clip, Removable (skin) (product code FZQ), Class I - General Controls.

Submitted by Temp-Stik Corp. (Mchenry, US). The FDA issued a Cleared decision on November 8, 1982 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4320 - 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 Temp-Stik Corp. devices

FDA 510(k) Submission Details - K822963

510(k) Number K822963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1982
Decision Date November 08, 1982
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

FZQ Device Classification - Class 1, General Controls

Product Code FZQ Clip, Removable (skin)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4320
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.