Cleared Traditional

K982306 - POLYTUBE

K982306 · Ferris Mfg. Corp. · General & Plastic Surgery device
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Sep 1998
Decision
83d
Days
-
Risk

K982306 is an FDA 510(k) clearance for the POLYTUBE. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Ferris Mfg. Corp. (Burr Ridge, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 83 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 Ferris Mfg. Corp. devices

FDA 510(k) Submission Details - K982306

510(k) Number K982306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1998
Decision Date September 22, 1998
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
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 89
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K982306.
BIONECT HYDROGEL FOAM
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BIONECT HYDROGEL SPRAY
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BIONECT CLEAR HYDROGEL
K973725 · Fidia Pharmaceutical 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
X-CELL WOUND DRESSING
K974251 · Xylos Corporation · Jun 1998