510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781797Substantially Equivalent

Prep Tray, Preoperative Skin

Pharmaseal Div., Baxter Healthcare Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781797 is the FDA 510(k) clearance record for PREP TRAY, PREOPERATIVE SKIN, a class I device, cleared for Pharmaseal Div., Baxter Healthcare Corp. on under FDA product code OJU (Skin Prep Tray). FDA's definition for product code OJU reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 24 510(k) clearances for Pharmaseal Div., Baxter Healthcare Corp., from to . As of , FDA records show no recalls naming K781797.

Clearance record

Decision date
Received
(16 days to decision)
Product code
OJU Skin Prep Tray
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Pharmaseal Div., Baxter Healthcare Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code OJU

Trailing 12 months

FDA records hold no clearances under product code OJU in the trailing twelve months.

FDA records show no clearances under product code OJU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OJU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260