Nerve Capping Device— 510(k) K152684

Substantially Equivalent

Polyganics Innovations BV

FDA 510(k) clearance K152684 for Nerve Capping Device, Substantially Equivalent on 2016-01-13. Applicant: Polyganics Innovations BV. Device class: 2.

Clearance details

Applicant: Polyganics Innovations BV
Product code: Code JXI
Device class: Class 2
Regulation: 21 CFR 882.5275
Advisory panel: Neurology
Date received: 2015-09-18
Decision date: 2016-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Groningen, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXI

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K242113 — Nerve Wrap (07-DW-001-TAB)2025-04-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.