510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914358Substantially Equivalent

Encapsulated Guidewire with Flexible Tip

Hobbs Medical, Inc., Stafford Springs CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914358 is the FDA 510(k) clearance record for ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP, a class II device, cleared for Hobbs Medical, Inc. on under FDA product code EYB (Catheter, Ureteral, Gastro-Urology). FDA records list 21 510(k) clearances for Hobbs Medical, Inc., from to . As of , FDA records show one recall naming K914358.

Clearance record

Decision date
Received
(49 days to decision)
Product code
EYB Catheter, Ureteral, Gastro-Urology
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Hobbs Medical, Inc. P.O. Box 46, Stafford Springs CT
510(k) summary
Summary
Third party review
No

Clearances, product code EYB

Trailing 12 months

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

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