Avid-Nit Cervical Regional Anesthesia Needle
FDA 510(k) K000117 · Avid Medical, Inc.
510(k) numberK000117
Submission
- Device name
- Avid-Nit Cervical Regional Anesthesia Needle
- Applicant
- Avid Medical, Inc.
Toano, VA, US - Received
- January 14, 2000
- Decision date
- April 13, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K052365 | Cervineedle Disposable Cartridge SyringeHEE · Traditional | Rocket Medical Plc | 10/17/2005SE |
| K021224 | Endocervical Block NeedleHEE · Traditional | Wallach Surgical Devices, Inc. | 07/12/2002SE |
| 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 |
More from CooperSurgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001731 | Avid-Nit Loss of Resistance SyringeFMF · Traditional | 08/29/2000SE |
Questions and answers
When was Avid-Nit Cervical Regional Anesthesia Needle cleared by the FDA?
Avid-Nit Cervical Regional Anesthesia Needle (K000117) received a 510(k) decision of Substantially Equivalent on April 13, 2000, 90 days after the submission was received.
What is the product code of K000117?
The FDA product code is HEE – Set, Anesthesia, Paracervical, a Class II (moderate risk) device regulated under 21 CFR 884.5100.