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NEUROCAP 2.5 mm

by Polyganics Innovations B.V.

NEUROCAP 2.5 mm (NC01-025/03) is a Class II device made by Polyganics Innovations B.V., cleared under FDA 510(k) K152684 on 13 Jan 2016 and listed in FDA GUDID since 2 Feb 2016 (UDI-DI 08717703990256), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K152684

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08717703990256 UDI-DI Date2 Feb 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152684 Date13 Jan 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152684 decided 13 Jan 2016 Active
  • FDA GUDID UDI-DI 08717703990256 listed 2 Feb 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152684
  2. Listed FDA GUDID 08717703990256

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Neurocap
Generic name
Nerve guide, synthetic polymer, bioabsorbable
Model / Ref / Catalog
2.5 mm, NC01-025/03
Primary DI / UDI-DI
08717703990256
510(k) Number
FDA product code
JXI
GMDN term
Nerve guide, synthetic polymer, bioabsorbable
Device class
Class II
Regulation number
882.5275
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Nerve guide, synthetic polymer, bioabsorbable

Cleared under the same submission (K152684)

and 4 more cleared under K152684

Similar devices

Other devices filed under FDA product code JXI (Cuff, Nerve).

Other devices from Polyganics Innovations B.V.

  • Neurolac TW 3.0 mm

    Class II

  • NEUROCAP 7.0 mm

    Class II

  • NEUROCAP 5.0 mm

    Class II

  • NEUROCAP 2.0 mm

    Class II

See all devices from Polyganics Innovations B.V. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)