510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882637Substantially Equivalent

Accu-Culshure Tm

Accu-Med Corp., Pleasantville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882637 is the FDA 510(k) clearance record for ACCU-CULSHURE TM, a class I device, cleared for Accu-Med Corp. on under FDA product code JTX (Transport Systems, Anaerobic). FDA records list one 510(k) clearance for Accu-Med Corp. As of , FDA records show no recalls naming K882637.

Clearance record

Decision date
Received
(9 days to decision)
Product code
JTX Transport Systems, Anaerobic
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Accu-Med Corp. 270 Marble Ave., Pleasantville NY
Third party review
No

Clearances, product code JTX

Trailing 12 months

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

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