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FDA 510(k)

Theia NPWT Foam Wound Dressing Kit

K-Number: K211277 · 2021-12-16

ApplicantClear Choice Therapeutics, Inc.
Decision Date2021-12-16
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Theia NPWT Foam Wound Dressing Kit is a medical device manufactured by Clear Choice Therapeutics, Inc.. It received FDA 510(k) clearance on 2021-12-16 under approval number K211277. 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 Theia NPWT Foam Wound Dressing Kit?

Theia NPWT Foam Wound Dressing Kit is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by Clear Choice Therapeutics, Inc.. The 510(k) number is K211277.

When was Theia NPWT Foam Wound Dressing Kit approved by the FDA?

Theia NPWT Foam Wound Dressing Kit received FDA 510(k) clearance on 2021-12-16, under approval number K211277.

What company makes Theia NPWT Foam Wound Dressing Kit?

Theia NPWT Foam Wound Dressing Kit is manufactured by Clear Choice Therapeutics, Inc..

What is the FDA product code for Theia NPWT Foam Wound Dressing Kit?

The FDA product code for Theia NPWT Foam Wound Dressing Kit is OMP.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40574448 [Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

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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