Bolt Navigation BN001-02

by Circinus Medical Technology, LLC

Bolt Navigation BN001-02 is a Class II device made by Circinus Medical Technology, LLC, cleared under FDA 510(k) K213768 on 1 Dec 2022 and listed in FDA GUDID since 15 Nov 2024 (UDI-DI BN981BN001021), 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	NumberBN981BN001021 UDI-DI	Date15 Nov 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK213768	Date1 Dec 2022Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K213768

Across registries

2 registries list this device

FDA 510(k) K213768 decided 1 Dec 2022 Active
FDA GUDID UDI-DI BN981BN001021 listed 15 Nov 2024 Listed

Timeline

2 dated events

1 Dec 2022 Cleared FDA 510(k) K213768
15 Nov 2024 Listed FDA GUDID BN981BN001021

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Bolt Navigation
Generic name: Surgical planning/navigation-enhancement system
Model / Ref / Catalog: BN001-02

Primary DI / UDI-DI: BN981BN001021
510(k) Number: K213768
FDA product code: OWB
GMDN term: Surgical planning/navigation-enhancement system

Device class: Class II
Regulation number: 892.1650
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Surgical planning/navigation-enhancement system.

Other devices from Circinus Medical Technology, LLC

Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)