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FDA 510(k)

PWD Platform Wound Dressing 3” x 5” Oblong

K-Number: K191460 · 2019-07-02

ApplicantApplied Tissue Technologies, LLC
Decision Date2019-07-02
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PWD Platform Wound Dressing 3” x 5” Oblong is a medical device manufactured by Applied Tissue Technologies, LLC. It received FDA 510(k) clearance on 2019-07-02 under approval number K191460. 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 PWD Platform Wound Dressing 3” x 5” Oblong?

PWD Platform Wound Dressing 3” x 5” Oblong is a medical device that received FDA 510(k) clearance on 2019-07-02. It is manufactured by Applied Tissue Technologies, LLC. The 510(k) number is K191460.

When was PWD Platform Wound Dressing 3” x 5” Oblong approved by the FDA?

PWD Platform Wound Dressing 3” x 5” Oblong received FDA 510(k) clearance on 2019-07-02, under approval number K191460.

What company makes PWD Platform Wound Dressing 3” x 5” Oblong?

PWD Platform Wound Dressing 3” x 5” Oblong is manufactured by Applied Tissue Technologies, LLC.

What is the FDA product code for PWD Platform Wound Dressing 3” x 5” Oblong?

The FDA product code for PWD Platform Wound Dressing 3” x 5” Oblong 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)

Other Devices by Applied Tissue Technologies, LLC

K182409Applied Tissue Technologies PWD™ Platform Wound Dressing K212359PWD 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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