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FDA 510(k)

Nisus Touch Negative Pressure Wound Therapy Pump

K-Number: K203693 · 2021-08-13

ApplicantCork Medical Products, LLC
Decision Date2021-08-13
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Nisus Touch Negative Pressure Wound Therapy Pump is a medical device manufactured by Cork Medical Products, LLC. It received FDA 510(k) clearance on 2021-08-13 under approval number K203693. 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 Nisus Touch Negative Pressure Wound Therapy Pump?

Nisus Touch Negative Pressure Wound Therapy Pump is a medical device that received FDA 510(k) clearance on 2021-08-13. It is manufactured by Cork Medical Products, LLC. The 510(k) number is K203693.

When was Nisus Touch Negative Pressure Wound Therapy Pump approved by the FDA?

Nisus Touch Negative Pressure Wound Therapy Pump received FDA 510(k) clearance on 2021-08-13, under approval number K203693.

What company makes Nisus Touch Negative Pressure Wound Therapy Pump?

Nisus Touch Negative Pressure Wound Therapy Pump is manufactured by Cork Medical Products, LLC.

What is the FDA product code for Nisus Touch Negative Pressure Wound Therapy Pump?

The FDA product code for Nisus Touch Negative Pressure Wound Therapy Pump is OMP.

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Related PubMed Literature

PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

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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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