Venturi Negative Pressure Wound Therapy System

Q: What is the product code of K080897?

The FDA product code is OMP – Negative Pressure Wound Therapy Powered Suction Pump, a Class II (moderate risk) device regulated under 21 CFR 878.4780.

FDA 510(k) K080897 · Talley Medical

Substantially Equivalent

510(k) numberK080897

Submission

Device name: Venturi Negative Pressure Wound Therapy System
Applicant: Talley Medical
Williamston, MI, US
Received: March 31, 2008
Decision date: July 15, 2008
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OMP – Negative Pressure Wound Therapy Powered Suction Pump
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4780
Specialty: General, Plastic Surgery

For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Other 510(k)s with product code OMP

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K261338	RENASYS DYNAFLOW Kit (66807741)OMP · Traditional	Smith & Nephew Medical, Ltd.	09/11/2026SE
K253263	ConvaVAC Negative Pressure Wound Therapy SystemOMP · Traditional	Convatec Limited, Gdc Building	06/24/2026SE
K253199	Curasys 2 (EMDN0003)OMP · Traditional	CG Bio Co., Ltd.	06/23/2026SE
K260646	Renasys Edge (66803126)OMP · Traditional	Smith & Nephew Medical, Ltd.	05/27/2026SE
K261291	Nisus NPWT Canister 500-mL (CPC-500)OMP · Special	Cork Medical	05/21/2026SE
K254019	Wound Geni NPWT SystemOMP · Traditional	Bechtel Medical, Inc.	05/04/2026SE
K253429	Genadyne ASTRA NPWTOMP · Traditional	Genadyne Biotechnologies, Inc.	03/12/2026SE
K250586	Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional	Deroyal Industries, Inc.	11/21/2025SE
K251646	extriCARE® 1000 Negative Pressure Wound Therapy SystemOMP · Traditional	Alleva Medical Devices	10/03/2025SE
K251826	RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP · Traditional	Smith & Nephew Medical, Ltd.	09/11/2025SE

More from Smith & Nephew Medical, Ltd.

510(k)	Device	Decision
K090258	Venturi NPWT V. II Advanced Vacuum SystemOMP · Traditional	08/25/2009SE
K080763	Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HTDWJ · Traditional	05/30/2008SE

Questions and answers

When was Venturi Negative Pressure Wound Therapy System cleared by the FDA?

Venturi Negative Pressure Wound Therapy System (K080897) received a 510(k) decision of Substantially Equivalent on July 15, 2008, 106 days after the submission was received.

What is the product code of K080897?

The FDA product code is OMP – Negative Pressure Wound Therapy Powered Suction Pump, a Class II (moderate risk) device regulated under 21 CFR 878.4780.