Cleared Traditional

K841008 - BIOPSY PUNCH, VARIOUS (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K841008 · Premier Dental Products Co. · General & Plastic Surgery device
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Jun 1984
Decision
91d
Days
Class 1
Risk

K841008 is an FDA 510(k) clearance for the BIOPSY PUNCH, VARIOUS. Classified as Brush, Biopsy, General & Plastic Surgery (product code GEE), Class I - General Controls.

Submitted by Premier Dental Products Co. (Walker, US). The FDA issued a Cleared decision on June 8, 1984 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Premier Dental Products Co. devices

Submission Details

510(k) Number K841008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1984
Decision Date June 08, 1984
Days to Decision 91 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
23d faster than avg
Panel avg: 114d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEE Brush, Biopsy, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.