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FDA 510(k)

PolyPlex Wound Dressing

K-Number: K160872 · 2016-11-23

ApplicantGlobal Health Solutions, LLC
Decision Date2016-11-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PolyPlex Wound Dressing is a medical device manufactured by Global Health Solutions, LLC. It received FDA 510(k) clearance on 2016-11-23 under approval number K160872. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PolyPlex Wound Dressing?

PolyPlex Wound Dressing is a medical device that received FDA 510(k) clearance on 2016-11-23. It is manufactured by Global Health Solutions, LLC. The 510(k) number is K160872.

When was PolyPlex Wound Dressing approved by the FDA?

PolyPlex Wound Dressing received FDA 510(k) clearance on 2016-11-23, under approval number K160872.

What company makes PolyPlex Wound Dressing?

PolyPlex Wound Dressing is manufactured by Global Health Solutions, LLC.

What is the FDA product code for PolyPlex Wound Dressing?

The FDA product code for PolyPlex Wound Dressing is FRO. This falls under the Anesthesiology category.

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 Global Health Solutions, LLC

K171191Hexagen Derm

Related Devices (Code: FRO)

K160695Talymed SuspensionMarine Polymer Technologies, Inc. K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc. K152533Xonrid GelHelsinn Healthcare SA K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC K153565DONASORB SILVER WOUND DRESSINGVirchow Biotech Pvt, Ltd.

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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