Cleared Traditional

K820106 - X-RAY GUAZE SPONGES

K820106 · Stan-Pak Ent. · General & Plastic Surgery device
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Feb 1982
Decision
28d
Days
-
Risk

K820106 is an FDA 510(k) clearance for the X-RAY GUAZE SPONGES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Stan-Pak Ent. (Mchenry, US). The FDA issued a Cleared decision on February 12, 1982 after a review of 28 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 Stan-Pak Ent. devices

FDA 510(k) Submission Details - K820106

510(k) Number K820106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1982
Decision Date February 12, 1982
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
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 156
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K820106.
FLORET PEANUT SPONGE/STICK & GAUZE PREP
K830274 · Ritmed, Inc. · Mar 1983
DOSOMETRIC RELEASE STERILIZATION
K823058 · Stan-Pak Ent. · Dec 1982
NU-GAUZE SPONGE
K821150 · Johnson & Johnson Professionals, Inc. · Aug 1982
GUAZE SPONGES, PLAIN
K820107 · Stan-Pak Ent. · Feb 1982
CONVERTORS STERILE DISP. LAP SPONGE II
K813296 · American Convertors Div., American Pharmaseal · Dec 1981
SOFTCARE BARRIER WET DRESSING
K812736 · The Kendal Co. · Nov 1981