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
K012556Substantially Equivalent

Reprocessed Guidewires

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

K012556 is the FDA 510(k) clearance record for REPROCESSED GUIDEWIRES, a class II device, cleared for Sterilmed, Inc. on under FDA product code NML (Catheter, Biliary, Reprocessed). FDA's definition for product code NML reads: "same as "FGE" except being reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". FDA records list 65 510(k) clearances for Sterilmed, Inc., from to . As of , FDA records show one recall naming K012556.

Clearance record

Decision date
Received
(264 days to decision)
Product code
NML Catheter, Biliary, Reprocessed
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sterilmed, Inc. 11400 73rd Ave. N, Maple Grove MN
510(k) summary
Summary
Third party review
No

Clearances, product code NML

Trailing 12 months

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

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