Company ยท GB
Rocket Medical Plc
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2021. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
7recalls (6 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GBX | Catheter, Irrigation | 6 |
| DWM | Apparatus, Suction, Patient Care | 3 |
| MQE | Needle, Assisted Reproduction | 2 |
| MQF | Catheter, Assisted Reproduction | 2 |
| PNG | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | 2 |
| DQX | Wire, Guide, Catheter | 1 |
| GXI | Probe, Radiofrequency Lesion | 1 |
| HEE | Set, Anesthesia, Paracervical | 1 |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 |
| ICX | Aniline | 1 |
| KDQ | Bottle, Collection, Vacuum | 1 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 1 |
| MFD | Cannula, Intrauterine Insemination | 1 |
| MPR | Stent, Bladder, Fetal | 1 |
| MQG | Accessory, Assisted Reproduction | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 2021 | K210509 | Rocket Platinum Cured Cathter Rocket Medical Plc, GB | DWM |
| Aug 17, 2017 | K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit Rocket Medical Plc, GB | DWM |
| Nov 14, 2016 | K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit Rocket Medical Plc, GB | PNG |
| Mar 29, 2016 | K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set Rocket Medical Plc, GB | PNG |
| Feb 1, 2013 | K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B Rocket Medical Plc, GB | DWM |
| Oct 17, 2005 | K052365 | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE Rocket Medical Plc, GB | HEE |
| Nov 24, 2004 | K042264 | GUIDEWIRES Rocket Medical Plc, GB | DQX |
| Oct 4, 2004 | K040189 | ENDOMETRIAL SAMPLING SYRINGE Rocket Medical Plc | HHK |
| Aug 8, 2003 | K032015 | EMBRYON ULTRASOUND NEEDLE GUIDE Rocket Medical Plc, GB | MQE |
| Apr 19, 2000 | K000340 | HYSTALOG HSG CATHETER Rocket Medical Plc, GB | HES |
| Apr 19, 2000 | K000205 | EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES Rocket Medical Plc, GB | MQE |
| Mar 21, 2000 | K994344 | NEUROTHERM RF CANNULA Rocket Medical Plc, GB | GXI |
| Mar 9, 2000 | K000656 | EMBRYON GIFT TRANSFER CATHETERS/SETS Rocket Medical Plc, GB | MQF |
| Feb 29, 2000 | K000394 | CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT Rocket Medical Plc, GB | MQG |
| Feb 28, 2000 | K994327 | EMBRYON TRANSFER CATHETERS/SETS Rocket Medical Plc, GB | MQF |
| Mar 2, 1998 | K980061 | EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER Rocket Medical Plc | MFD |
| Feb 11, 1998 | K972856 | ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS Rocket Medical Plc, GB | KNF |
| Oct 24, 1997 | K972867 | CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT Rocket Medical Plc, GB | ICX |
| Jul 26, 1996 | K961287 | ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM Rocket Medical Plc, GB | KDQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | Rocket Medical Plc Brand Name: Rocket
Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray
Model/Catalog Number: R54549-20-PK
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with fene Open, Classified |
GBX | None listed |
| Dec 18, 2025 | Rocket Medical Plc Brand Name: Rocket
Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray
Model/Catalog Number: R54549-16-PK
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with fene Open, Classified |
GBX | None listed |
| Dec 18, 2025 | Rocket Medical Plc Brand Name: Rocket
Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard
Model/Catalog Number: R54544-18-SG
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with f Open, Classified |
GBX | None listed |
| Dec 18, 2025 | Rocket Medical Plc Brand Name: Rocket
Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray
Model/Catalog Number: R54544-18-PK
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with fene Open, Classified |
GBX | None listed |
| Dec 18, 2025 | Rocket Medical Plc Brand Name: Rocket
Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard
Model/Catalog Number: R54544-12-SG
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with f Open, Classified |
GBX | None listed |
| Dec 18, 2025 | Rocket Medical Plc Brand Name: Rocket
Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray
Model/Catalog Number: R54544-12-PK
Product Description: Chest tube manufactured from PVC, with fenestrations and a barium Open, Classified |
GBX | None listed |
| Aug 1, 2019 | Rocket Medical Plc Rocket KCH Fetal Bladder Drainage Catheter
Model: R57405 Terminated |
MPR | None listed |