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FDA 510(k)

PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System

K-Number: K203716 · 2021-12-14

ApplicantSmith and Nephew Medical Limited
Decision Date2021-12-14
Product CodeQFC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew Medical Limited. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K203716. The device is classified under product code QFC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System?

PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Smith and Nephew Medical Limited. The 510(k) number is K203716.

When did PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2021-12-14, under 510(k) number K203716.

Who is the listed applicant for PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System?

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

What is the FDA product code for PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System?

The FDA product code for PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System is QFC.

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_RECRUITINGNCT06025253PINTA - Prophylactic Incisional Negative Pressure Therapy for Major AmputationsRECRUITINGNCT06717308Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.RECRUITINGNCT07653165Use of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity WoundsENROLLING_BY_INVITATIONNCT07607366Effects of Negative Pressure Wound Bandaging After MastectomyRECRUITINGNCT04955730NPWT in Patients Undergoing Surgical Procedures for Management of GI MalignanciesCOMPLETED

Other records listing Smith and Nephew Medical Limited as applicant

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.

K213853RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large

Related Devices (Code: QFC)

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.

K223263Prevena Plus 125 Therapy Unit3M

Official Source

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

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