510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012581Substantially Equivalent

Reprocessed Stone Retrieval Baskets

Sterilmed Inc, Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012581 is the FDA 510(k) clearance record for REPROCESSED STONE RETRIEVAL BASKETS, a class II device, cleared for Sterilmed, Inc. on under FDA product code FFL (Dislodger, Stone, Basket, Ureteral, Metal). FDA records list 65 510(k) clearances for Sterilmed, Inc., from to . As of , FDA records show one recall naming K012581.

Clearance record

Decision date
Received
(189 days to decision)
Product code
FFL Dislodger, Stone, Basket, Ureteral, Metal
Regulation
21 CFR 876.4680
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sterilmed, Inc. 11400 73rd Ave. N Suite 100, Maple Grove MN
510(k) summary
Summary
Third party review
No

Clearances, product code FFL

Trailing 12 months

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

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