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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 the device name listed in this FDA 510(k) record. The listed applicant is Pensar Medical, LLC. It received FDA 510(k) clearance on 2020-10-23 under 510(k) 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. The listed applicant is Pensar Medical, LLC. The 510(k) number is K200223.

When did PocketDoc™ Micro Wound Therapy System receive FDA 510(k) clearance?

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

Who is the listed applicant for PocketDoc™ Micro Wound Therapy System?

The FDA 510(k) record lists Pensar Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Pensar Medical, LLC 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.

K150960WoundPro Negative Pressure Wound Therapy System

Related Devices (Code: OMP)

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.

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound 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.

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