Cleared Traditional

K843783 - WET PACK

K843783 · E.M. Adams · General & Plastic Surgery device
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Dec 1984
Decision
84d
Days
-
Risk

K843783 is an FDA 510(k) clearance for the WET PACK. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by E.M. Adams (Medfield, US). The FDA issued a Cleared decision on December 19, 1984 after a review of 84 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 E.M. Adams devices

FDA 510(k) Submission Details - K843783

510(k) Number K843783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1984
Decision Date December 19, 1984
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 85
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K843783.
DRESSING, FIRST AID, FIELD, VARIOUS SIZES
K863850 · Fraass Survival Systems, Inc. · Oct 1986
STERILE LAPAROTOMY GAUZE SPONGE
K862126 · Anago, Inc. · Jun 1986
STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE
K852202 · Ormed Mfg., Inc. · Jun 1985
FLORET STRUNG GAUZE SPONGES
K830261 · Ritmed, Inc. · Jun 1983
FLORET KITTNER OR K DISSECTOR
K830266 · Ritmed, Inc. · Jun 1983
FLORET SPECIAL GAUZE SPONGES
K830267 · Ritmed, Inc. · Jun 1983