510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K092969Substantially Equivalent

H/s Catheter Set 5 French, Model 61-5005F, H/s Catheter Set 7 French, Model 61-5007F

Sterling Medical, Inc., Goldsboro NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092969 is the FDA 510(k) clearance record for H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F, a class II device, cleared for Sterling Medical, Inc. on under FDA product code LKF (Cannula, Manipulator/Injector, Uterine). FDA records list one 510(k) clearance for Sterling Medical, Inc. As of , FDA records show no recalls naming K092969.

Clearance record

Decision date
Received
(217 days to decision)
Product code
LKF Cannula, Manipulator/Injector, Uterine
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sterling Medical, Inc. 683 N. Spence Ave., Goldsboro NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LKF

Trailing 12 months
2 clearances under product code LKF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LKF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260