Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008320103

FEI Number

3008320103

Entity Name

IVT MEDICAL LTD.

City/State/Country

Raanana Central, IL

Establishment Address

16 Hatidhar St., Raanana Central 4366518, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IVT Medical Ltd. (Owner Number: 10031887)

Owner / Operator Contact Address

16 Hatidhar St., Raanana, IL-M 4366518, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121817

PMA Number

N/A

All Registered Proprietary Names

TopClosure® 3S System TopClosure® 1SAD TopClosure® 1SM Top Closure TopClosure® 1S System TopClosure TopBase Vcare Alpha

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MKY	System, Skin Closure	General, Plastic Surgery	Class 1	878.4320	2010-03-18
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2014-05-05

Official Correspondent

Moris Topaz

US Agent Details

Geoffrey Brahmer Email: gbrahmer@gmail.com Phone: (781) 6408769

Related Public Records

Same Entity

IVT Medical Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008320103. Last updated year: 2026. Please use registration number 3008320103 when referencing this establishment in official correspondence.