510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231422Substantially Equivalent

Precision GI

Limaca Medical Ltd, En Ha'Emeq, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231422 is the FDA 510(k) clearance record for Precision GI, a class II device, cleared for Limaca Medical, Ltd. on under FDA product code FCG (Biopsy Needle). FDA records list one 510(k) clearance for Limaca Medical, Ltd. As of , FDA records show no recalls naming K231422.

Clearance record

Decision date
Received
(103 days to decision)
Product code
FCG Biopsy Needle
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Limaca Medical, Ltd. 3 Ha'Rimon St., En Ha'Emeq, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FCG

Trailing 12 months

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

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