Cleared Traditional

K945313 - SPARTA HYDROGEL WOUND DRESSING

K945313 · Sparta Surgical Corp. · General & Plastic Surgery device
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Jan 1995
Decision
72d
Days
-
Risk

K945313 is an FDA 510(k) clearance for the SPARTA HYDROGEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Sparta Surgical Corp. (Hammonton, US). The FDA issued a Cleared decision on January 12, 1995 after a review of 72 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.

FDA 510(k) Submission Details - K945313

510(k) Number K945313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1994
Decision Date January 12, 1995
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
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 144
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K945313.
DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING
K946030 · Wilshire Medical Products · Feb 1995
DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING
K946031 · Wilshire Medical Products · Feb 1995
ARGIDENE(TM) GEL
K945835 · Telios Pharmaceuticals, Inc. · Feb 1995
CARRASYN FDG
K944427 · Carrington Laboratories, Inc. · Nov 1994
HYDRODERM GEL WOUND DRESSING
K944333 · Wilshire Medical Products · Nov 1994
BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTS
K943470 · Levtrade Intl. (Pty) , Ltd. · Sep 1994
K945313 · SPARTA HYDROGEL WOUND DRESSING
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