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Nerbridge

by Toyobo Co., Ltd.

510(k) K152967

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04965838907456 UDI-DI Date27 Jul 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK152967 Date22 Jun 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Generic Name
Nerve guide, animal-derived
Model / Ref / Catalog
RN03525E
Primary DI / UDI-DI
04965838907456
510(k) Number
FDA Product Code
JXI
GMDN Term
Nerve guide, animal-derived
Device Class
Class II
Regulation
21 CFR Part 882.5275
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
Not in Commercial Distribution

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No