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Rocket R51400

by Rocket Medical Plc

Rocket R51400 is a device made by Rocket Medical Plc, cleared under FDA 510(k) K123033 on 1 Feb 2013 and listed in FDA GUDID since 8 Sep 2016 (UDI-DI 05055270965813), 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) K123033

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 Number05055270965813 UDI-DI Date8 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123033 Date1 Feb 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123033 decided 1 Feb 2013 Active
  • FDA GUDID UDI-DI 05055270965813 listed 8 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123033
  2. Listed FDA GUDID 05055270965813

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  • Withdrawn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
Fixed-diameter cervical dilator, reusable
Model / Ref / Catalog
R51400
Primary DI / UDI-DI
05055270965813
510(k) Number
GMDN term
Fixed-diameter cervical dilator, reusable
GUDID distribution status
In Commercial Distribution

Related devices

Category: Fixed-diameter cervical dilator, reusable

Cleared under the same submission (K123033)

and 8 more cleared under K123033

Other devices from Rocket Medical Plc

See all devices from Rocket Medical Plc →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)