Cleared Traditional

K831183 - GAUZE SPONGE STERILE SPONGE

K831183 · Den Med, Inc. · General & Plastic Surgery device
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Jun 1983
Decision
58d
Days
-
Risk

K831183 is an FDA 510(k) clearance for the GAUZE SPONGE STERILE SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Den Med, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 58 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 Den Med, Inc. devices

FDA 510(k) Submission Details - K831183

510(k) Number K831183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1983
Decision Date June 08, 1983
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
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 K831183.
FLORET KITTNER OR K DISSECTOR
K830266 · Ritmed, Inc. · Jun 1983
FLORET SPECIAL GAUZE SPONGES
K830267 · Ritmed, Inc. · Jun 1983
FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN
K830268 · Ritmed, Inc. · Jun 1983
FLORET TONSIL & ADENOID SPONGES
K830264 · Ritmed, Inc. · Jun 1983
FLORET NEURO SPONGE
K830269 · Ritmed, Inc. · Jun 1983
LAPET & LAPWALL LAPAROTOMY SPONGES
K830271 · Ritmed, Inc. · Jun 1983