Cleared Traditional

K980132 - PHYTACARE ALGINATE HYDROGEL WOUND DRESSING

K980132 · Phytatek Laboratories, Inc. · General & Plastic Surgery device
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Jun 1998
Decision
162d
Days
-
Risk

K980132 is an FDA 510(k) clearance for the PHYTACARE ALGINATE HYDROGEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Phytatek Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on June 26, 1998 after a review of 162 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Phytatek Laboratories, Inc. devices

FDA 510(k) Submission Details - K980132

510(k) Number K980132 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 15, 1998
Decision Date June 26, 1998
Days to Decision 162 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 115d · This submission: 162d
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 K980132.
BIONECT CLEAR HYDROGEL
K973725 · Fidia Pharmaceutical Corp. · Sep 1998
POLYTUBE
K982306 · Ferris Mfg. Corp. · Sep 1998
BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO
K980962 · Brennen Medical, Inc. · Jul 1998
X-CELL WOUND DRESSING
K974251 · Xylos Corporation · Jun 1998
SOLOSITE GEL CONFORMABLE DRESSING
K981150 · Smith & Nephew, Inc. · Jun 1998
DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL
K980861 · Dumex Medical Surgical Products, Ltd. · May 1998