Cleared Traditional

K981150 - SOLOSITE GEL CONFORMABLE DRESSING

K981150 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
83d
Days
-
Risk

K981150 is an FDA 510(k) clearance for the SOLOSITE GEL CONFORMABLE DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Smith & Nephew, Inc. (Largo, US). The FDA issued a Cleared decision on June 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 Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K981150

510(k) Number K981150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1998
Decision Date June 22, 1998
Days to Decision 83 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
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 K981150.
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
DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL
K980861 · Dumex Medical Surgical Products, Ltd. · May 1998
FLEXIGEL-G HYDROGEL WOUND DRESSING
K980097 · Innovative Technologies , Ltd. · Mar 1998
DUODERM HYDROACTIVE GEL
K973806 · Convatec, A Bristol-Myers Squibb Co. · Dec 1997