FDA 510(k)

PICO 7 Single Use Negative Pressure Wound Therapy System

K-Number: K172005 · 2018-02-02

Decision Date2018-02-02

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PICO 7 Single Use Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2018-02-02 under 510(k) number K172005. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICO 7 Single Use Negative Pressure Wound Therapy System?

PICO 7 Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K172005.

When did PICO 7 Single Use Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

PICO 7 Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2018-02-02, under 510(k) number K172005.

Who is the listed applicant for PICO 7 Single Use Negative Pressure Wound Therapy System?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PICO 7 Single Use Negative Pressure Wound Therapy System?

The FDA product code for PICO 7 Single Use Negative Pressure Wound Therapy System is OMP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07770633Negative Pressure Wound Therapy Devices in Total Knee ArthroplastyNOT_YET_RECRUITING NCT06025253PINTA - Prophylactic Incisional Negative Pressure Therapy for Major AmputationsRECRUITING NCT06717308Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.RECRUITING NCT07653165Use of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity WoundsENROLLING_BY_INVITATION NCT07607366Effects of Negative Pressure Wound Bandaging After MastectomyRECRUITING NCT04955730NPWT in Patients Undergoing Surgical Procedures for Management of GI MalignanciesCOMPLETED

Other records listing Smith & Nephew Medical Limited as applicant

K260646RENASYS EDGE (66803126)K251826RENASYS WOUND+ Dressing Kit with AIRLOCK Technology K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port K242146BIOBRANE Temporary Wound Dressing; BIOBRANE Glove K231939Renasys Edge K223526ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing

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Related Devices (Code: OMP)

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.