Cleared Traditional

K984266 - MODIFICATION OF BIONECT HYDROGEL SPRAY

K984266 · Fidia Pharmaceutical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
85d
Days
-
Risk

K984266 is an FDA 510(k) clearance for the MODIFICATION OF BIONECT HYDROGEL SPRAY. 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 February 10, 1999 after a review of 85 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 Fidia Pharmaceutical Corp. devices

FDA 510(k) Submission Details - K984266

510(k) Number K984266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1998
Decision Date February 10, 1999
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
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 K984266.
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K984368 · Molnlycke Health Care, Inc. · Feb 1999
MODIFICATION OF BIONECT HYDROGEL GAUZE PADS
K984262 · Fidia Pharmaceutical Corp. · Feb 1999
MODIFICATION OF BIONECT CLEAR HYDROGEL
K984264 · Fidia Pharmaceutical Corp. · Feb 1999
MODIFICATION OF BIONECT HYDROGEL FOAM
K984267 · Fidia Pharmaceutical Corp. · Feb 1999
BIONECT HYDROGEL
K984413 · Fidia Pharmaceutical Corp. · Feb 1999
BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET
K984082 · Emox 911 CC · Jan 1999