510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K884397Substantially Equivalent for Some Indications

Pharmaseal Sterile Wound Care Dressing

Baxter Healthcare Corporation, Valencia CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K884397 is the FDA 510(k) clearance record for PHARMASEAL STERILE WOUND CARE DRESSING, cleared for Baxter Healthcare Corp on under FDA product code FRO (Dressing, Wound, Drug). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K884397.

Clearance record

Decision date
Received
(69 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Baxter Healthcare Corp 27200 N. Tourney Rd., Valencia CA
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