ROCKET MEDICAL PLC

FDA Device Registration & Listing · WASHINGTON Sunderland, GB · Registration 9610632

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9610632
FEI Number
3002808026
Entity Name
ROCKET MEDICAL PLC
City/State/Country
WASHINGTON Sunderland, GB
Establishment Address
Sedling Road, WASHINGTON Sunderland NE38 9BZ, GB
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
Rocket Medical Plc (Owner Number: 8010022)
Owner / Operator Contact Address
Sedling Road, --, Washington, GB-SND NE38 9BZ, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

ET Catheters #K994327 For the placement of embryos Heimlich Valve IPC Bottles and accessories Pleural Vent R53902 Disposable Sigmoidoscope Insufflation Sets Rocket Medical Needle Guides Rocket Peritoneal Catheter & Accessories Thoracentesis Seldinger Chest Drain Kit R54544-12-00 / 18-00 etc Thoracic Catheters Pleural Drain Set Needle Drains Blunt Dissection Kits R58800 Range - Drainage Catheters Chest Aspiration Set IVF Devices Aspiration & Collection #K000205 R57687 Filter Set for Cook K-MAR 5200 Pump R57685 Water Trap Set for CRAFT Suction Pumps R57686 Filter Set for Oocyte Aspiration Pump #K000394 R29660 CRAFT DUO VAC Suction Pump (240V) R29661 CRAFT DUO VAC Suction Pump (110v) R57008-00-CN Copeland Foetal Scalp Electrode for Qwik Connect Cables #K844608 R57008-00-FM Copeland Foetal Scalp Electrode for Philips Avalon Cables

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2007-11-27
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2015-08-19
FCY Bulb, Inflation, For Endoscope Gastroenterology, Urology Class 1 876.1500 2014-05-28
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2007-11-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2007-11-27
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2016-04-20
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2008-07-10
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2007-11-27
NVT Tubing And Tubing/Filter Fits Obstetrics/Gynecology Class 1 884.1700 2007-11-27
MQG Accessory, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6120 2007-11-27
HGP Electrode, Circular (Spiral), Scalp And Applicator Obstetrics/Gynecology Class 2 884.2675 2007-02-21

Official Correspondent

No official correspondent registered.

US Agent Details

Toby Tyson Business: Rocket Medical LLC Email: usa@rocketmedical.com Phone: (781) 7496223

Related Public Records

Same Entity

Rocket Medical Plc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K112396 Kitazato Medical Co., Ltd. IUI CATHETERS 2012-11-02
K082727 Vitrolife Sweden AB FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN 2009-02-06
K882805 Coopervision-Cilco CILCO VILLASENOR PACHYMETER 1988-08-12
K791040 Shimadzu Corp. SECTOR SCANNER, SDU-100, COMPUTERIZED 1979-10-04
K162372 Qt Ultrasound, LLC QT Ultrasound Breast Scanner-1 2017-06-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011 Verathon, Inc. 2
AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011 Verathon, Inc. 2
BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014 SonoSite, Inc. 2
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0029-2020 CooperSurgical, Inc. 2
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.

Similar Registrations

Registration Number Establishment Name Location
3005987240 ALLWIN MEDICAL DEVICES, INC. ANAHEIM, CA, US
1820334 Cook Incorporated Bloomington, IN, US
3010155661 Synergy Health Sterilisation UK Ltd Thorne Doncaster, GB
3003995932 VITROLIFE SWEDEN AB Vastra Frolunda Vastra Gotaland, SE
3030447506 PHARMCO MEDICAL BV ROTTERDAM Zuid-Holland, NL
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610632. Last updated year: 2026. Please use registration number 9610632 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.