Cleared Traditional

K983348 - DYNAREX TRACHEOSTOMY SPONGE

K983348 · Dynarex Corp. · General & Plastic Surgery device
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Dec 1998
Decision
79d
Days
-
Risk

K983348 is an FDA 510(k) clearance for the DYNAREX TRACHEOSTOMY SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Dynarex Corp. (Brewster, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 79 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 Dynarex Corp. devices

FDA 510(k) Submission Details - K983348

510(k) Number K983348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1998
Decision Date December 11, 1998
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

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