Cleared Traditional

CATHETER CARE KIT REORDER 7940&7941 (K791888) - FDA 510(k) Clearance

K791888 · Ascep, Inc. · General & Plastic Surgery device
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Oct 1979
Decision
36d
Days
-
Risk

K791888 is an FDA 510(k) clearance for the CATHETER CARE KIT REORDER 7940&7941. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Ascep, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979 after a review of 36 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 Ascep, Inc. devices

Submission Details

510(k) Number K791888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1979
Decision Date October 17, 1979
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -