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 the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies. It received FDA 510(k) clearance on 2019-09-27 under 510(k) 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. The listed applicant is Genadyne Biotechnologies. The 510(k) number is K182722.

When did XLR8 Abdominal Wound Dressing Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for XLR8 Abdominal Wound Dressing Kit?

The FDA 510(k) record lists Genadyne Biotechnologies as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06326203Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb IschemiaNOT_YET_RECRUITING NCT07676370PROV-MESH: Prophylactic Ovarian Cancer MESHRECRUITING

Other records listing Genadyne Biotechnologies as applicant

K253429Genadyne ASTRA NPWT K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)K233614Genadyne DUO NPWT K221888Genadyne Hybrid Foam Dressings K221891UNO Negative Pressure Wound Therapy System K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System

View all 10 devices →

Related Devices (Code: OMP)

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

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.