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Rocket R29661

by Rocket Medical Plc

Rocket R29661 is a Class II device made by Rocket Medical Plc, cleared under FDA 510(k) K000394 on 29 Feb 2000 and listed in FDA GUDID since 24 Oct 2023 (UDI-DI 05055270911636), 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) K000394

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 Number05055270911636 UDI-DI Date24 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK000394 Date29 Feb 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K000394 decided 29 Feb 2000 Active
  • FDA GUDID UDI-DI 05055270911636 listed 24 Oct 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K000394
  2. Listed FDA GUDID 05055270911636

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rocket
Generic name
Surgical suction pump
Model / Ref / Catalog
R29661
Primary DI / UDI-DI
05055270911636
510(k) Number
FDA product code
GCX
GMDN term
Surgical suction pump
Device class
Class II
Regulation number
880.6740
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical suction pump

Cleared under the same submission (K000394)

Similar devices in this category

Other devices filed under Surgical suction pump.

Other devices from Rocket Medical Plc

See all devices from Rocket Medical Plc →

Properties

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