510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813335Substantially Equivalent

Percutaneous Transhepatic Cholang. Tray

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

K813335 is the FDA 510(k) clearance record for PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY, a class I device, cleared for American Pharmaseal Div. Ahsc on under FDA product code FSH (Tray, Surgical, Needle). FDA records list 64 510(k) clearances for American Pharmaseal Div. Ahsc, from to . As of , FDA records show no recalls naming K813335.

Clearance record

Decision date
Received
(45 days to decision)
Product code
FSH Tray, Surgical, Needle
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 FSH

Trailing 12 months

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

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