FDA 510(k)

XLR8 Abdominal Wound Dressing Kit

K-Number: K182722 · 2019-09-27

Decision Date2019-09-27

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

XLR8 Abdominal Wound Dressing Kit is a medical device manufactured by Genadyne Biotechnologies. It received FDA 510(k) clearance on 2019-09-27 under approval number K182722. 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 XLR8 Abdominal Wound Dressing Kit?

XLR8 Abdominal Wound Dressing Kit is a medical device that received FDA 510(k) clearance on 2019-09-27. It is manufactured by Genadyne Biotechnologies. The 510(k) number is K182722.

When was XLR8 Abdominal Wound Dressing Kit approved by the FDA?

XLR8 Abdominal Wound Dressing Kit received FDA 510(k) clearance on 2019-09-27, under approval number K182722.

What company makes XLR8 Abdominal Wound Dressing Kit?

XLR8 Abdominal Wound Dressing Kit is manufactured by Genadyne Biotechnologies.

What is the FDA product code for XLR8 Abdominal Wound Dressing Kit?

The FDA product code for XLR8 Abdominal 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 NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_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

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 Genadyne Biotechnologies

K190028UNO 30

Related Devices (Code: OMP)

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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.