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FDA 510(k)

PocketDoc™ Micro Wound Therapy System

K-Number: K200223 · 2020-10-23

ApplicantPensar Medical, LLC
Decision Date2020-10-23
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PocketDoc™ Micro Wound Therapy System is a medical device manufactured by Pensar Medical, LLC. It received FDA 510(k) clearance on 2020-10-23 under approval number K200223. 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 PocketDoc™ Micro Wound Therapy System?

PocketDoc™ Micro Wound Therapy System is a medical device that received FDA 510(k) clearance on 2020-10-23. It is manufactured by Pensar Medical, LLC. The 510(k) number is K200223.

When was PocketDoc™ Micro Wound Therapy System approved by the FDA?

PocketDoc™ Micro Wound Therapy System received FDA 510(k) clearance on 2020-10-23, under approval number K200223.

What company makes PocketDoc™ Micro Wound Therapy System?

PocketDoc™ Micro Wound Therapy System is manufactured by Pensar Medical, LLC.

What is the FDA product code for PocketDoc™ Micro Wound Therapy System?

The FDA product code for PocketDoc™ Micro Wound Therapy System is OMP.

Related Clinical Trials

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

Other Devices by Pensar Medical, LLC

K150960WoundPro Negative Pressure Wound Therapy System

Related Devices (Code: OMP)

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC

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.

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