510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122078Substantially Equivalent

Lofric Primo, Lofric Hydro-Kit

Astra Tech, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122078 is the FDA 510(k) clearance record for LOFRIC PRIMO, LOFRIC HYDRO-KIT, a class II device, cleared for Astra Tech, Inc. on under FDA product code EZD (Catheter, Straight). FDA records list 38 510(k) clearances for Astra Tech, Inc., from to . As of , FDA records show 3 recalls naming K122078.

Clearance record

Decision date
Received
(107 days to decision)
Product code
EZD Catheter, Straight
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Astra Tech, Inc. 11234 El Camino Real, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZD

Trailing 12 months
11 clearances under product code EZD in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EZD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20261
April 20262
May 20261
June 20261
July 20262
August 20261
September 20261
October 20260