Drill Bit 352-01

by Neurovention LLC

Drill Bit 352-01 is a Class II device made by Neurovention LLC, cleared under FDA 510(k) K192162 on 13 Mar 2020 and listed in FDA GUDID since 21 Jun 2022 (UDI-DI G28435201), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberG28435201 UDI-DI	Date21 Jun 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK192162	Date13 Mar 2020Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K192162

Across registries

2 registries list this device

FDA 510(k) K192162 decided 13 Mar 2020 Active
FDA GUDID UDI-DI G28435201 listed 21 Jun 2022 Listed

Timeline

2 dated events

13 Mar 2020 Cleared FDA 510(k) K192162
21 Jun 2022 Listed FDA GUDID G28435201

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Drill Bit
Generic name: Fluted surgical drill bit, single-use
Model / reference: 352-01

Primary DI / UDI-DI: G28435201
510(k) Number: K192162
FDA product code: HBG
GMDN term: Fluted surgical drill bit, single-use

Device class: Class II
Regulation number: 882.4300
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Neurovention LLC

See all devices from Neurovention LLC →

Properties

Sterilise before use
Single use
Prescription use
Lot / batch number

Other properties (11, all answered No)