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CoBot, Drill Bit A40041

by Ecential Robotics

CoBot, Drill Bit A40041 is a Class II device made by Ecential Robotics, cleared under FDA 510(k) K231886 on 27 Jul 2023 (1 earlier submission) and listed in FDA GUDID since 4 Sep 2023 (UDI-DI 03701311500704), active as of 22 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 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03701311500704 UDI-DI Date4 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK231886 Date27 Jul 2023IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231886 decided 27 Jul 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 03701311500704 listed 4 Sep 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K221028
  2. Cleared FDA 510(k) K231886
  3. Listed FDA GUDID 03701311500704

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CoBot, Drill Bit
Generic name
Fluted surgical drill bit, reusable
Model / reference
A40041
Primary DI / UDI-DI
03701311500704
510(k) Number
FDA product code
OLO
GMDN term
Fluted surgical drill bit, reusable
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Fluted surgical drill bit, reusable

Cleared under the same submission (K221028)

and 4 more cleared under K221028

Cleared under the same submission (K231886)

and 4 more cleared under K231886

Similar devices in this category

Other devices filed under Fluted surgical drill bit, reusable.

Other devices from Ecential Robotics

See all devices from Ecential Robotics →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)