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NEXA Negative Pressure Wound Therapy System

by Nexa Medical, Ltd. United Kingdom 510(k)

510(k) K162610 Product code OMP

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK162610 Date8 Jun 2017ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
OMP
FDA applicant
Nexa Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K162610 24 fields · synced 22 Oct 2026