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The Rocket IPC Platinum Cured Catheter is intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites that do not respond to medical management of underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice.

The Rocket IPC Platinum Cured Catheter is a fenestrated silicone drainage catheter indicated for intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites that do not respond to medical management of underlying disease. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent collected air and fluid from migrating back into the body. The Rocket platinum Cured Catheter is used alongside the Rocket IPC drainage line and Rocket IPC bottles (these we included in the Rocket Indwelling Pleural Catheter (IPC) System (K123033) & Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K152105).

The Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (Model # R51400-16-PL and R51400-MI-PL) is indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of underlying disease. The device is indicated for: - The palliation of dyspnea due to pleural effusion - Providing pleurodesis (resolution of the pleural effusion) This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines.

Model R51400-16-PL IPC Insertion Kit consists of the IPC, drainage line and accessories for insertion, attachment and dressing. In addition, it contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x 2). Model R51400-MI-PL is the Mini Kit with fewer accessories and no drugs. It is for use by surgeons where the patients are already draped and insertion components are readily available. The Rocket IPC Insertion Kits are provided sterile and are for single use only. The Rocket Indwelling Pleural Catheter (IPC) is a fenestrated silicone catheter, with a barium sulfate stripe through its length, intended for the drainage of pleural effusion. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the pleural space. This valve can only be operated with the specifically designed drainage line and drainage bottles supplied by Rocket Medical.

The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is intermittent drainage of symptomatic. recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.

The Rocket Indwelling Peritoneal Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. The catheter has a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the peritoneum. The IPC Insertion Kit consists of the IPC, drainage line and accessories for insertion, attachment and dressing. In addition, the Rocket IPC Insertion Kit contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x 2).

The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is intermittent drainage of symptomatic, recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.

Rocket Medical Plc. hereby submits this Traditional 510(k) notice for its Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. The Rocket Indwelling Peritoneal Catheter is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the peritoneum. The IPC Insertion Kit will consist of the IPC and components necessary for its use such as a drainage line. In addition, the Rocket IPC is packaged into convenience kits to aid in the implantation of the Rocket IPC.

The Rocket IPC Insertion Kit and the Rocket IPC Dressing Pack and Bottle Set are indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines. The devices are indicated for: 1. The palliation of dyspnea due to pleural effusion 2. Providing pleurodesis (resolution of the pleural effusion). The Rocket IPC Bottle Sets are indicated for use only with the Rocket Indwelling Pleural Catheter for intermittent drainage. The Rocket Dressing Packs are indicated for dressing of a catheter and exit site.

The Rocket Indwelling Pleural Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of pleural effusions. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent collected air and fluid from migrating back into the pleural cavity. The IPC System will consist of the IPC and components necessary for its' use such as convenience kits to aid in the implantation of the Rocket IPC.

For injection of solutions (such as lidocaine with or without 1:100,000 eninephine) into the cervix. This application includes outlines that require local anaesthetics such as loop excision (LEEP), elecro-fulguration, CO2 laser excision and vaporization, and when required, endocervical curettage and cervical biopsies. For use with 2.2ml glass vials, such as those containing local anaesthetic agents.

CerviNeedle™ Disposable Cartridge Syringe

The Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel - excluding use in coronary arteries and in the neurovasculature.

This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA

The Endometrial Sampling Syringe can be used for a variety of clinical conditions which could include the following: - For histological biopsy of the endometrium & endo-cervix in post menopausal screening. . - Hormone therapy monitoring. . - Endometrial dating . - Detection of endometrial carcinoma . - Bacterial culturing .

This device is being designed to allow the safe and effective the histologic biopsy of the endomethum "and" endometrial carcinoma, endometrial dating and bacterial culturing. This is achieved by a design where the slim form of the sampling syringe makes in most This is actieved by a dealer which as a polypropylene sheath permitting easy entry into the uterine cavity. The sheath / cannula mechanism gives good suction and when combined with the shape and form of the curette opening gives good sample extraction.

Ultrasound Needle Guides are for the attachment of needles to specified ultrasound transducers. For use in ultrasound guided oocyte harvesting and tissue biopsy.

This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA Re-usable ultrasound needle guides have been in use for over 20 years. The device is safe and effective for the application for which it is intended. More recently concerns about cross infection and patient pain have produced some single use versions being in use for the past 3 years, without any known incident in the UK.