Cleared Traditional

K990974 - VITOP DRESSING

K990974 · Wonder & Bioenergy Hi-Tech America, Inc. · General & Plastic Surgery device
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Jun 1999
Decision
78d
Days
-
Risk

K990974 is an FDA 510(k) clearance for the VITOP DRESSING. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Wonder & Bioenergy Hi-Tech America, Inc. (Monterey Park, US). The FDA issued a Cleared decision on June 9, 1999 after a review of 78 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 Wonder & Bioenergy Hi-Tech America, Inc. devices

FDA 510(k) Submission Details - K990974

510(k) Number K990974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1999
Decision Date June 09, 1999
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 156
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K990974.
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
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GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
K990584 · Broadline Medical Industries · Apr 1999
CROSSTEX NON-WOVEN SPONGES
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K983016 · Vitalcare Group, Inc. · Feb 1999
DYNAREX TRACHEOSTOMY SPONGE
K983348 · Dynarex Corp. · Dec 1998