Cleared Traditional

K991287 - SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA

K991287 · Advanced Medical Solutions Group Plc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
76d
Days
-
Risk

K991287 is an FDA 510(k) clearance for the SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions Group Plc (Winsford, Cheshire, GB). The FDA issued a Cleared decision on June 29, 1999 after a review of 76 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 Advanced Medical Solutions Group Plc devices

FDA 510(k) Submission Details - K991287

510(k) Number K991287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1999
Decision Date June 29, 1999
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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