Cleared Traditional

K984595 - MODIFICATION OF CUTINOVA HYDRO DRESSING

K984595 · Beiersdorf-Jobt, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
63d
Days
-
Risk

K984595 is an FDA 510(k) clearance for the MODIFICATION OF CUTINOVA HYDRO DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Beiersdorf-Jobt, Inc. (Charlotte, US). The FDA issued a Cleared decision on March 1, 1999 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 Beiersdorf-Jobt, Inc. devices

FDA 510(k) Submission Details - K984595

510(k) Number K984595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1998
Decision Date March 01, 1999
Days to Decision 63 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
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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