510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K801965Substantially Equivalent

Custom Universal Cutdown Prep Tray

American Pharmaseal Div. Ahsc, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801965 is the FDA 510(k) clearance record for CUSTOM UNIVERSAL CUTDOWN PREP TRAY, a class I device, cleared for American Pharmaseal Div. Ahsc on under FDA product code FSM (Tray, Surgical, Instrument). FDA records list 64 510(k) clearances for American Pharmaseal Div. Ahsc, from to . As of , FDA records show no recalls naming K801965.

Clearance record

Decision date
Received
(52 days to decision)
Product code
FSM Tray, Surgical, Instrument
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
American Pharmaseal Div. Ahsc 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FSM

Trailing 12 months

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

FDA records show no clearances under product code FSM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FSM, 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