Cleared Traditional

K821701 - RAPIDO-LASTIC IN STERILE FORM

K821701 · Conco Medical Co. · General & Plastic Surgery device
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Jul 1982
Decision
44d
Days
-
Risk

K821701 is an FDA 510(k) clearance for the RAPIDO-LASTIC IN STERILE FORM. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Conco Medical Co. (Mchenry, US). The FDA issued a Cleared decision on July 22, 1982 after a review of 44 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 Conco Medical Co. devices

FDA 510(k) Submission Details - K821701

510(k) Number K821701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1982
Decision Date July 22, 1982
Days to Decision 44 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
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 157
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K821701.
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K820107 · Stan-Pak Ent. · Feb 1982
CONVERTORS STERILE DISP. LAP SPONGE II
K813296 · American Convertors Div., American Pharmaseal · Dec 1981