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FG02550

by Covidien LP

FG02550 is a Class II device made by Covidien LP, cleared under FDA 510(k) K061188 on 23 Oct 2006 and listed in FDA GUDID since 1 Oct 2016 (UDI-DI 00821684074176), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K061188

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00821684074176 UDI-DI Date1 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK061188 Date23 Oct 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061188 decided 23 Oct 2006 Active
  • FDA GUDID UDI-DI 00821684074176 listed 1 Oct 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1162-2010 FDA Unclassified (pre-2012) initiated 21 Jan 2010

    ev3 Inc. is conducting a voluntary recall of specific lots of the SilverHawk Cutter Drivers (Model Number FG 02550) because of damage to the packaging.

Timeline

3 dated events

  1. Cleared FDA 510(k) K061188
  2. Recall initiated FDA recalls Z-1162-2010
  3. Listed FDA GUDID 00821684074176

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Mechanical atherectomy system catheter, peripheral
Model / reference
FG02550
Primary DI / UDI-DI
00821684074176
510(k) Number
FDA product code
MCW
GMDN term
Mechanical atherectomy system catheter, peripheral
Device class
Class II
Regulation number
870.4875
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Related devices

Category: Mechanical atherectomy system catheter, peripheral

Cleared under the same submission (K061188)

and 4 more cleared under K061188

Similar devices

Other devices filed under FDA product code MCW (Catheter, peripheral, atherectomy).

Other devices from Covidien LP

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    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)