Cleared Traditional

K973725 - BIONECT CLEAR HYDROGEL

K973725 · Fidia Pharmaceutical Corp. · General & Plastic Surgery device
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Sep 1998
Decision
357d
Days
-
Risk

K973725 is an FDA 510(k) clearance for the BIONECT CLEAR HYDROGEL. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Fidia Pharmaceutical Corp. (Washington, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Fidia Pharmaceutical Corp. devices

FDA 510(k) Submission Details - K973725

510(k) Number K973725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1997
Decision Date September 22, 1998
Days to Decision 357 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
242d slower than avg
Panel avg: 115d · This submission: 357d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 65
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K973725.
BIONECT HYDROGEL GAUZE PADS
K973721 · Fidia Pharmaceutical Corp. · Sep 1998
BIONECT HYDROGEL FOAM
K973722 · Fidia Pharmaceutical Corp. · Sep 1998
BIONECT HYDROGEL SPRAY
K973724 · Fidia Pharmaceutical Corp. · Sep 1998
POLYTUBE
K982306 · Ferris Mfg. Corp. · Sep 1998
BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO
K980962 · Brennen Medical, Inc. · Jul 1998
PHYTACARE ALGINATE HYDROGEL WOUND DRESSING
K980132 · Phytatek Laboratories, Inc. · Jun 1998