FDA 510(k)

Applied Tissue Technologies PWD Platform Wound Dressing

K-Number: K182409 · 2019-01-11

ApplicantApplied Tissue Technologies, LLC

Decision Date2019-01-11

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Applied Tissue Technologies PWD Platform Wound Dressing is a medical device manufactured by Applied Tissue Technologies, LLC. It received FDA 510(k) clearance on 2019-01-11 under approval number K182409. 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 Applied Tissue Technologies PWD Platform Wound Dressing?

Applied Tissue Technologies PWD Platform Wound Dressing is a medical device that received FDA 510(k) clearance on 2019-01-11. It is manufactured by Applied Tissue Technologies, LLC. The 510(k) number is K182409.

When was Applied Tissue Technologies PWD Platform Wound Dressing approved by the FDA?

Applied Tissue Technologies PWD Platform Wound Dressing received FDA 510(k) clearance on 2019-01-11, under approval number K182409.

What company makes Applied Tissue Technologies PWD Platform Wound Dressing?

Applied Tissue Technologies PWD Platform Wound Dressing is manufactured by Applied Tissue Technologies, LLC.

What is the FDA product code for Applied Tissue Technologies PWD Platform Wound Dressing?

The FDA product code for Applied Tissue Technologies PWD Platform Wound Dressing is OMP.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT07040683 Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study RECRUITING NCT07370051 Effect of Topical Oxygen and LED Light Therapy on Nipple Crack NOT_YET_RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING

Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 40969652 Risk-sharing agreements for medical devices: a stakeholder-based qualitative study in Czechia. Frontiers in public health (2025) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) 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

K191460PWD Platform Wound Dressing 3 x 5 Oblong 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.