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FDA 510(k)

Innomed NPWT Silicone Foam Dressing

K-Number: K202823 · 2021-12-15

ApplicantZhejiang Longterm Medical Technology Co., Ltd.
Decision Date2021-12-15
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Innomed NPWT Silicone Foam Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K202823. 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 Innomed NPWT Silicone Foam Dressing?

Innomed NPWT Silicone Foam Dressing is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K202823.

When did Innomed NPWT Silicone Foam Dressing receive FDA 510(k) clearance?

Innomed NPWT Silicone Foam Dressing received FDA 510(k) clearance on 2021-12-15, under 510(k) number K202823.

Who is the listed applicant for Innomed NPWT Silicone Foam Dressing?

The FDA 510(k) record lists Zhejiang Longterm Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Innomed NPWT Silicone Foam Dressing?

The FDA product code for Innomed NPWT Silicone Foam Dressing is OMP.

Other records listing Zhejiang Longterm Medical Technology Co., Ltd. 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.

K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitK192478LT Antibacterial Alginate with Silver DressingK182458Longterm NPWT Foam Dressing Kit

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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