Cleared Traditional

K820195 - OR SPECIALTIES VAGINAL PACK

K820195 · Howard Medical Co. · General & Plastic Surgery device
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Mar 1982
Decision
39d
Days
-
Risk

K820195 is an FDA 510(k) clearance for the OR SPECIALTIES VAGINAL PACK. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Howard Medical Co. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1982 after a review of 39 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 Howard Medical Co. devices

FDA 510(k) Submission Details - K820195

510(k) Number K820195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1982
Decision Date March 05, 1982
Days to Decision 39 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
76d faster than avg
Panel avg: 115d · This submission: 39d
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 K820195.
FLORET PEANUT SPONGE/STICK & GAUZE PREP
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DOSOMETRIC RELEASE STERILIZATION
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NU-GAUZE SPONGE
K821150 · Johnson & Johnson Professionals, Inc. · Aug 1982
X-RAY GUAZE SPONGES
K820106 · Stan-Pak Ent. · Feb 1982
GUAZE SPONGES, PLAIN
K820107 · Stan-Pak Ent. · Feb 1982
CONVERTORS STERILE DISP. LAP SPONGE II
K813296 · American Convertors Div., American Pharmaseal · Dec 1981