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HawkOne™ H1-S

by Covidien LP 3 variants

HawkOne™ H1-S is a Class II device made by Covidien LP, cleared under FDA 510(k) K161361 on 14 Oct 2016 and listed in FDA GUDID since 29 Oct 2016 (UDI-DI 00643169728783), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K161361

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 Number00643169728783 UDI-DI Date29 Oct 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161361 Date14 Oct 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161361 decided 14 Oct 2016 Active
  • FDA GUDID UDI-DI 00643169728783 listed 29 Oct 2016 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0450-2022 FDA Class I initiated 6 Dec 2021
    • Terminated Z-0451-2022 FDA Class I initiated 6 Dec 2021

    Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.

Timeline

4 dated events

  1. Cleared FDA 510(k) K161361
  2. Listed FDA GUDID 00643169728783
  3. Recall initiated FDA recalls Z-0450-2022
  4. Recall initiated FDA recalls Z-0451-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
HawkOne™
Generic name
Mechanical atherectomy system catheter, peripheral
Model / reference
H1-S
Primary DI / UDI-DI
00643169728783
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
Not in Commercial Distribution
Size
Length — 145.0 Centimeter
Outer Diameter — 2.2 Millimeter
Catheter Gauge — 6.0 French

Related devices

Category: Mechanical atherectomy system catheter, peripheral

Cleared under the same submission (K161361)

Similar devices

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

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
Other properties (12, all answered No)