510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K801885Substantially Equivalent

Hancock * Obturators

Hancock Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801885 is the FDA 510(k) clearance record for HANCOCK * OBTURATORS, a class I device, cleared for Hancock Laboratories, Inc. on under FDA product code DTI (Sizer, Heart-Valve, Prosthesis). FDA records list 5 510(k) clearances for Hancock Laboratories, Inc., from to . As of , FDA records show no recalls naming K801885.

Clearance record

Decision date
Received
(33 days to decision)
Product code
DTI Sizer, Heart-Valve, Prosthesis
Regulation
21 CFR 870.3945
Device class
Class I
Review panel
Cardiovascular
Applicant
Hancock Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DTI

Trailing 12 months

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

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