Percutx-Injection/Aspiration Needle Probes/Devices
FDA 510(k) K994151 · Ximed/Prosure/Injectx
510(k) numberK994151
Submission
- Device name
- Percutx-Injection/Aspiration Needle Probes/Devices
- Applicant
- Ximed/Prosure/Injectx
San Jose, CA, US - Received
- December 9, 1999
- Decision date
- March 1, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GAA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223625 | CapnoSpot Pneumothorax Decompression IndicatorGAA · Traditional | Pneumeric, Inc. | 03/28/2023SE |
| K102274 | Arvik Laparoscopic Aspiration InstrumentGAA · Traditional | Arvik Enterprises/ Mini Lap Technologies | 06/15/2011SE |
| K011586 | Irma SL Blood Analysis System GL CartridgeGAA · Traditional | Diametrics Medical, Inc. | 11/16/2001SE |
| K983200 | Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexGAA · Traditional | Ximed/Prosure/Injectx | 12/11/1998SE |
| K974741 | Manan Accura NeedleGAA · Traditional | Medical Device Technologies, Inc. | 01/08/1998SE |
| K962425 | Bonopty Coaxial Bone Biopsy System with Eccentric DRILL(10-1072,3,4)GAA · Traditional | Radi Medical Systems AB | 09/11/1996SE |
| K961959 | MD Tech Biopsy Set for Bone and Bone MarrowGAA · Traditional | Medical Device Technologies, Inc. | 07/19/1996SE |
| K945109 | Monoject Bone Marrow Biopsy TraysGAA · Traditional | Sherwood Medical Co. | 11/14/1994SE |
| K940025 | Manan Bone Marrow Harvest NeedlesGAA · Traditional | Manan Medical Products, Inc. | 02/25/1994SE |
| K940024 | Manan General Purpose Introducer NeedleGAA · Traditional | Manan Medical Products, Inc. | 02/25/1994SE |
More from Manan Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002269 | Electrosurgical Probes and Devices-GeltxGEI · Traditional | 01/04/2001SE |
| K983765 | Injection Needle Probe/Device-TunisFBK · Traditional | 12/11/1998SE |
| K983200 | Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexGAA · Traditional | 12/11/1998SE |
| K981256 | Isolated Saline Electrodes/Probes/Devices-SalinetrodeFAS · Traditional | 05/12/1998SE |
| K974484 | Isolated Electrosurgical Probes and Devices-SalinetrodeGEI · Traditional | 02/10/1998SE |
| K974637 | Electrodes/Probes/DevicesFAS · Traditional | 01/07/1998SE |
| K962593 | Electrosurgical Probes & DevicesGEI · Traditional | 11/12/1996SE |
| K945995 | Bipolar Electrosurgical Probes and InstrumentsGEI · Traditional | 01/31/1995SE |
Questions and answers
When was Percutx-Injection/Aspiration Needle Probes/Devices cleared by the FDA?
Percutx-Injection/Aspiration Needle Probes/Devices (K994151) received a 510(k) decision of Substantially Equivalent on March 1, 2000, 83 days after the submission was received.
What is the product code of K994151?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.