510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891870Substantially Equivalent

Intrasite* Gel (3) Year Shelf Life

Smith & Nephew United, Inc., Largo FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891870 is the FDA 510(k) clearance record for INTRASITE* GEL (3) YEAR SHELF LIFE, cleared for Smith & Nephew United, Inc. on under FDA product code FRO (Dressing, Wound, Drug). FDA records list 34 510(k) clearances for Smith & Nephew United, Inc., from to . As of , FDA records show no recalls naming K891870.

Clearance record

Decision date
Received
(152 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Smith & Nephew United, Inc. 11775 Starkley Rd., Largo FL
Third party review
No

Clearances, product code FRO

Trailing 12 months
19 clearances under product code FRO in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FRO, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20261
March 20263
April 20261
May 20261
June 20263
July 20260
August 20262
September 20262
October 20260