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COXO C-Sailor Pro

by Foshan COXO Medical Instrument Co., Ltd.

COXO C-Sailor Pro is a Class I device made by Foshan COXO Medical Instrument Co., Ltd., cleared under FDA 510(k) K220831 on 27 Sep 2022 and listed in FDA GUDID since 29 Oct 2026 (UDI-DI 06974267897045), active as of 9 Nov 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 9 Nov 2026

Documents

510(k) K220831

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974267897045 UDI-DI Date29 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK220831 Date27 Sep 2022IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220831 decided 27 Sep 2022 Active
  • FDA GUDID UDI-DI 06974267897045 listed 29 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220831
  2. Listed FDA GUDID 06974267897045

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Coxo
Generic name
Surgical power tool system control unit, line-powered
Model / reference
C-Sailor Pro
Primary DI / UDI-DI
06974267897045
510(k) Number
FDA product code
EBW, KMW, EGS
GMDN term
Surgical power tool system control unit, line-powered
Device class
Class I
Regulation number
872.4200, 872.4120
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code EBW (Controller, Foot, Handpiece And Cord).

Other devices from Foshan COXO Medical Instrument Co., Ltd.

See all devices from Foshan COXO Medical Instrument Co., Ltd. →

Properties

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