Cervineedle Disposable Cartridge Syringe
FDA 510(k) K052365 · Rocket Medical Plc
510(k) numberK052365
Submission
- Device name
- Cervineedle Disposable Cartridge Syringe
- Applicant
- Rocket Medical Plc
Tyne & Wear, GB - Received
- August 29, 2005
- Decision date
- October 17, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HEE – Set, Anesthesia, Paracervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5100
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HEE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021224 | Endocervical Block NeedleHEE · Traditional | Wallach Surgical Devices, Inc. | 07/12/2002SE |
| K000117 | Avid-Nit Cervical Regional Anesthesia NeedleHEE · Traditional | Avid Medical, Inc. | 04/13/2000SE |
| K983897 | Cervical Anesthesia Needle, Contracervical Anesthesia Needle, Model #'S 720209 30GAU X 4…HEE · Traditional | Ri Mos. S.R.L. | 02/01/1999SE |
| K980238 | Gynex Extended Reach NeedleHEE · Traditional | Gynex Corp. | 08/21/1998SE |
| K973671 | Endocervical Block NeedleHEE · Traditional | A & A Medical, Inc. | 11/26/1997SE |
| K954718 | Ellman Needle Extender/Measured Dose SyringeHEE · Traditional | Ellman Intl., Inc. | 02/29/1996SE |
| K910253 | Leep RedikitHEE · Traditional | CooperSurgical, Inc. | 04/18/1991SE |
| K910252 | Potocky Neddle (TM) Disposable Injection NeedleHEE · Traditional | CooperSurgical, Inc. | 03/04/1991SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K210509 | Rocket Platinum Cured CathterDWM · Traditional | 09/09/2021SESK |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion KitDWM · Traditional | 08/17/2017SE |
| K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitPNG · Traditional | 11/14/2016SEKD |
| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetPNG · Traditional | 03/29/2016SESK |
| K123033 | Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…DWM · Traditional | 02/01/2013SE |
| K042264 | GuidewiresDQX · Traditional | 11/24/2004SE |
| K040189 | Endometrial Sampling SyringeHHK · Traditional | 10/04/2004SE |
| K032015 | Embryon Ultrasound Needle GuideMQE · Traditional | 08/08/2003SE |
| K000340 | Hystalog HSG CatheterHES · Traditional | 04/19/2000SE |
| K000205 | Embryon Single and Double Lumen NeedlesMQE · Traditional | 04/19/2000SE |
Questions and answers
When was Cervineedle Disposable Cartridge Syringe cleared by the FDA?
Cervineedle Disposable Cartridge Syringe (K052365) received a 510(k) decision of Substantially Equivalent on October 17, 2005, 49 days after the submission was received.
What is the product code of K052365?
The FDA product code is HEE – Set, Anesthesia, Paracervical, a Class II (moderate risk) device regulated under 21 CFR 884.5100.