Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Galil Medical , Ltd. · Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

45 daysmedian FDA review time

113 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K181741	IceSphere 1.5 CX Cryoablation Needle	Galil Medical , Ltd.	2018-07-30	28	0
K162599	IcePearl 2.1 CX L, IceForce 2.1 CX L	Galil Medical , Ltd.	2016-10-11	22	0
K152133	IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostat	Galil Medical , Ltd.	2015-08-28	28	0
K141485	ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATIO	Galil Medical , Ltd.	2014-07-02	27	0
K140584	ICEROD CX CRYOABLATION NEEDLE	Galil Medical , Ltd.	2014-03-31	24	0
K121251	ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE	Galil Medical , Ltd.	2012-08-28	125	0
K110946	ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRY	Galil Medical , Ltd.	2011-06-21	78	0
K070482	ISIS	Galil Medical , Ltd.	2007-03-20	28	0
K060390	SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA	Galil Medical , Ltd.	2006-04-27	72	1
K060144	SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS	Galil Medical , Ltd.	2006-02-13	25	1
K052530	SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA	Galil Medical , Ltd.	2005-11-18	65	0
K051052	SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, C	Galil Medical , Ltd.	2005-05-06	11	1
K042667	SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT),	Galil Medical , Ltd.	2004-10-14	15	0
K031117	SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM	Galil Medical , Ltd.	2003-05-23	45	0
K021261	SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5,	Galil Medical , Ltd.	2002-07-03	75	1
K011950	SEEDNET, MODEL FP6T5, FP5T5, FP5T3	Galil Medical , Ltd.	2002-01-29	222	0
K012497	CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T	Galil Medical , Ltd.	2001-10-30	88	1
K010991	SEEDNET, MODELS FP6T5, FP5T5, FP5T3	Galil Medical , Ltd.	2001-05-03	30	1
K003065	SEEDNET, MODEL EP6T5, EP5E5	Galil Medical , Ltd.	2000-10-31	29	0
K993965	CRYO-HIT	Galil Medical , Ltd.	2000-02-18	87	0
K991517	CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5	Galil Medical , Ltd.	1999-07-27	88	0
K991272	CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EP	Galil Medical , Ltd.	1999-07-12	90	0
K980913	CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5	Galil Medical , Ltd.	1998-07-01	113	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda