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Drill FG2110

by Shanghai Kinetic Medical Co., Ltd.

Drill FG2110 is a Class II device made by Shanghai Kinetic Medical Co., Ltd., cleared under FDA 510(k) K113742 on 17 Sep 2012 and listed in FDA GUDID since 31 May 2020 (UDI-DI 06938695537645), 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

510(k) K113742

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06938695537645 UDI-DI Date31 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK113742 Date17 Sep 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113742 decided 17 Sep 2012 Active
  • FDA GUDID UDI-DI 06938695537645 listed 31 May 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K113742
  2. Listed FDA GUDID 06938695537645

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Drill
Generic name
Bone access channel kit
Model / Ref / Catalog
FG2110
Primary DI / UDI-DI
06938695537645
510(k) Number
FDA product code
HRX, NDN
GMDN term
Bone access channel kit
Device class
Class II
Regulation number
888.1100, 888.3027
GUDID distribution status
In Commercial Distribution
Size
Length — 220 Millimeter
Outer Diameter — 3.5 Millimeter

Related devices

Category: Bone access channel kit

Cleared under the same submission (K113742)

and 8 more cleared under K113742

Similar devices

Other devices filed under FDA product code HRX (Arthroscope).

Other devices from Shanghai Kinetic Medical Co., Ltd.

See all devices from Shanghai Kinetic Medical Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)