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ADAPT UNIVERSAL LAPAROSCOPIC PORT - 405940

FDA 510(k)

Class II (US FDA 510(k))

510(k) K082156

by Teleflex Medical

Identifiers

510(k) Number
K082156 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)
Models / Variants
405940 FDA 510(k)
405912 FDA 510(k)
40591213 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

ADAPT UNIVERSAL LAPAROSCOPIC PORT - 405940 by Teleflex Medical — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Teleflex Medical

Sources (1)

  • FDA 510(k) K082156 24 fields · synced Jun 18, 2026