Cleared Traditional

K821797 - ACTISORB* ACTIVATED CHARCOAL CLOTH DRSG. (FDA 510(k) Clearance)

K821797 · Johnson & Johnson Professionals, Inc. · General & Plastic Surgery device
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Sep 1982
Decision
88d
Days
-
Risk

K821797 is an FDA 510(k) clearance for the ACTISORB* ACTIVATED CHARCOAL CLOTH DRSG..

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on September 14, 1982 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K821797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1982
Decision Date September 14, 1982
Days to Decision 88 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
26d faster than avg
Panel avg: 114d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -