Set, Anesthesia, Paracervical
FDA product code HEE · Class II (moderate risk) · 21 CFR 884.5100 · Obstetrics/Gynecology
9510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052365 | Cervineedle Disposable Cartridge SyringeHEE · Traditional | Rocket Medical Plc | 10/17/2005SE |
| 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 |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0105-2016 Class III | CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical…Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials… | CooperSurgical, Inc. | 09/01/2015Terminated |