510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043241Substantially Equivalent

Lofric Hydro-Kit II Single Use Urinary Catheter

Astra Tech, Inc., Northborough MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043241 is the FDA 510(k) clearance record for LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER, a class II device, cleared for Astra Tech, Inc. on under FDA product code GBM (Catheter, Urethral). FDA records list 38 510(k) clearances for Astra Tech, Inc., from to . As of , FDA records show no recalls naming K043241.

Clearance record

Decision date
Received
(30 days to decision)
Product code
GBM Catheter, Urethral
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Astra Tech, Inc. 20 Main St., Northborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GBM

Trailing 12 months

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

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