Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010588638

FEI Number

3010588638

Entity Name

CORK MEDICAL, LLC

City/State/Country

Indianapolis, IN, US

Establishment Address

8000 Castleway Drive, Indianapolis, IN 46250, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Cork Medical Products, LLC (Owner Number: 10046132)

Owner / Operator Contact Address

8000 Castleway Drive, Indianapolis, IN 46250, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243187

PMA Number

N/A

All Registered Proprietary Names

Nisus Nisus VERSA Negative Pressure Wound Therapy System Cork Medical, LLC Forever Cushion Elite Balance Air Nisus ONE Negative Pressure Wound Therapy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2015-03-09
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2015-01-12
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2024-09-04
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2022-12-14
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2015-01-12
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2014-02-06
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2025-12-31

Official Correspondent

Patrick McGinley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cork Medical Products, LLC

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 3010588638. Last updated year: 2026. Please use registration number 3010588638 when referencing this establishment in official correspondence.