Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017397434

FEI Number

3017397434

Entity Name

CLEAR CHOICE THERAPEUTICS, INC.

City/State/Country

Raleigh, NC, US

Establishment Address

1053 E Whitaker Mill Rd Ste 115, Raleigh, NC 27604, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Clear Choice Therapeutics, Inc. (Owner Number: 10077792)

Owner / Operator Contact Address

310 S. West Street, Ste 200, Raleigh, NC 27603, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161570

PMA Number

N/A

All Registered Proprietary Names

PREVENT Barrier Wound Contact Layer NPWT Foam Wound Dressing Kit NPWT PREVENT Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-10-30
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2022-03-28
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2024-11-05
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2020-09-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Clear Choice Therapeutics, Inc.

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).

Similar Registrations

Registration Number	Establishment Name	Location
3027643662	ERIBIOTECH CO.,LTD	Suzhou Jiangsu, CN
3006607005	MOLNLYCKE HEALTH CARE (THAILAND), LTD.	Amphur Muang Chonburi Chon Buri, TH
3015432652	E.L.F. COSMETICS INC	Oakland, CA, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3015215566	THE HAIN CELESTIAL GROUP	Hoboken, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017397434. Last updated year: 2026. Please use registration number 3017397434 when referencing this establishment in official correspondence.