510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K920823Substantially Equivalent

Welter Snare Retriever

Cook Inc., Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920823 is the FDA 510(k) clearance record for WELTER SNARE RETRIEVER, a class II device, cleared for Cook, Inc. on under FDA product code DXE (Catheter, Embolectomy). FDA records list 163 510(k) clearances for Cook, Inc., from to . As of , FDA records show no recalls naming K920823.

Clearance record

Decision date
Received
(374 days to decision)
Product code
DXE Catheter, Embolectomy
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Cook, Inc. 925 S. Curry Pike, Bloomington IN
510(k) summary
Statement
Third party review
No

Clearances, product code DXE

Trailing 12 months

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

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