Cleared Traditional

K831635 - ACU-PUNCH (FDA 510(k) Clearance)

K831635 · Acuderm, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1983
Decision
48d
Days
-
Risk

K831635 is an FDA 510(k) clearance for the ACU-PUNCH.

Submitted by Acuderm, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 7, 1983 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel. 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 Acuderm, Inc. devices

Submission Details

510(k) Number K831635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1983
Decision Date July 07, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 77d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -