Cleared Traditional

K821732 - ARGYLE GERZOF ABCESS DRAINAGE CATHETER (FDA 510(k) Clearance)

K821732 · Sherwood Medical Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1982
Decision
25d
Days
-
Risk

K821732 is an FDA 510(k) clearance for the ARGYLE GERZOF ABCESS DRAINAGE CATHETER.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on July 9, 1982 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K821732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1982
Decision Date July 09, 1982
Days to Decision 25 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -