Cleared Traditional

K833867 - PAREMA K BAND NON-STERILE

K833867 · Mark One Healthcare Products · General & Plastic Surgery device
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Jan 1984
Decision
81d
Days
-
Risk

K833867 is an FDA 510(k) clearance for the PAREMA K BAND NON-STERILE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Mark One Healthcare Products (Walker, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 81 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.

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FDA 510(k) Submission Details - K833867

510(k) Number K833867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1983
Decision Date January 27, 1984
Days to Decision 81 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
34d faster than avg
Panel avg: 115d · This submission: 81d
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 87
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K833867.
STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE
K852202 · Ormed Mfg., Inc. · Jun 1985
WET PACK
K843783 · E.M. Adams · Dec 1984
DRY TRAY
K843782 · E.M. Adams · Dec 1984
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