Cleared Traditional

K973693 - AQUA PATCH

K973693 · Pci Technology · General & Plastic Surgery device
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Dec 1997
Decision
83d
Days
-
Risk

K973693 is an FDA 510(k) clearance for the AQUA PATCH. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Pci Technology (Dallas, US). The FDA issued a Cleared decision on December 18, 1997 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 Pci Technology devices

FDA 510(k) Submission Details - K973693

510(k) Number K973693 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 26, 1997
Decision Date December 18, 1997
Days to Decision 83 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
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 46
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K973693.
BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO
K980962 · Brennen Medical, Inc. · Jul 1998
SOLOSITE GEL CONFORMABLE DRESSING
K981150 · Smith & Nephew, Inc. · Jun 1998
DUODERM HYDROACTIVE GEL
K973806 · Convatec, A Bristol-Myers Squibb Co. · Dec 1997
AMERIGEL OINTMENT SATURATED WOUND DRESSING
K971918 · Amerx Health Care Corp. · Aug 1997
LAMIN-2 HYDRATING GEL
K970153 · Procyte Corp. · Jun 1997
OSMOCYTE WOUND MANAGER SHEET DRESSING
K965143 · Procyte Corp. · May 1997