Cleared Traditional

K980777 - DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING

K980777 · Dumex Medical Surgical Products, Ltd. · General & Plastic Surgery device
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May 1998
Decision
63d
Days
-
Risk

K980777 is an FDA 510(k) clearance for the DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Dumex Medical Surgical Products, Ltd. (Toronto, Orntario, CA). The FDA issued a Cleared decision on May 4, 1998 after a review of 63 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 Dumex Medical Surgical Products, Ltd. devices

FDA 510(k) Submission Details - K980777

510(k) Number K980777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1998
Decision Date May 04, 1998
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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