GALIL MEDICAL LTD.

FDA Device Registration & Listing · YOKNEAM Northern, IL · Registration 9616793

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9616793
FEI Number
3002843919
Entity Name
GALIL MEDICAL LTD.
City/State/Country
YOKNEAM Northern, IL
Establishment Address
Industrial Park, Tavor Building 1, YOKNEAM Northern 2069203, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Boston Scientific Corporation (Owner Number: 9912058)
Owner / Operator Contact Address
300 Boston Scientific Way, Marlborough, MA 01752, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K232635
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2024-11-19
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2019-10-11
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2019-10-11
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2019-10-11
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2019-10-11
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2019-10-11
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2019-10-11
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2019-10-11
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2019-10-11
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2019-10-11
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2019-10-11
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2019-10-11
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2019-10-11
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2019-10-11
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2024-02-28

Official Correspondent

No official correspondent registered.

US Agent Details

Aaron Dunbar Business: BOSTON SCIENTIFIC CORPORATION Email: aaron.dunbar@bsci.com Phone: (651) 3961414

Related Public Records

Same Entity

Boston Scientific Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3025434462 Obsidio Inc Maple Grove, MN, US
3005619880 Boston Scientific Corporation Roswell, GA, US
3015425075 NALU MEDICAL Carlsbad, CA, US
3015289131 FARAPULSE, INC. Menlo Park, CA, US
3022298579 Boston Scientific Cardiac Diagnostic Technologies, Inc. Arden Hills, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K190651 Erbe Elektromedizin GmbH ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter 2020-01-07
K760953 Spembly Medical , Ltd. DEEP FREEZE SYSTEM (DFS-30) 1976-11-16
K120857 Ncontact Surgical, Inc. EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX 2012-11-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Z-0011-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Z-0012-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Z-0013-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616793. Last updated year: 2026. Please use registration number 9616793 when referencing this establishment in official correspondence.
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