Symbiosis Bone Marrow Biopsy Needle
FDA 510(k) K925416 · Symbiosis Corp.
510(k) numberK925416
Submission
- Device name
- Symbiosis Bone Marrow Biopsy Needle
- Applicant
- Symbiosis Corp.
Miami, FL, US - Received
- October 27, 1992
- Decision date
- February 23, 1993
- 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
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| K102274 | Arvik Laparoscopic Aspiration InstrumentGAA · Traditional | Arvik Enterprises/ Mini Lap Technologies | 06/15/2011SE |
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| 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 |
More from Manan Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955119 | Symbiosis Monopolar Electrosurgical Roller ElectrodesHIH · Traditional | 01/18/1996SE |
| K953453 | Symbiosis Monopolar Electrosurgical Roller ElectrodesFAS · Traditional | 01/17/1996SE |
| K953242 | Symbiosis Monoplar Electrosurgical ElectrodesKNF · Traditional | 10/06/1995SE |
| K952432 | Symbiosis Bipolar ForcepsGEI · Traditional | 07/05/1995SE |
| K951387 | Symbiosis Bipolar ScissorsGCJ · Traditional | 04/10/1995SE |
| K950286 | Symbiosis Bipolar ScissorsGCJ · Traditional | 02/03/1995SE |
| K946238 | Symbiosis Gastrointestinal Biopsy ForcepsFCL · Traditional | 01/20/1995SE |
| K930773 | Symbiosis Gynecological Biopsy ForcepsHFB · Traditional | 07/28/1994SE |
| K941426 | Symbiosis Reusable Monopolar Electrosurgical ProbeGEI · Traditional | 06/22/1994SE |
| K932266 | Symbiosis Dispos Gastro Biopsy Forceps W/Reuse HanKGE · Traditional | 03/15/1994SE |
Questions and answers
When was Symbiosis Bone Marrow Biopsy Needle cleared by the FDA?
Symbiosis Bone Marrow Biopsy Needle (K925416) received a 510(k) decision of Substantially Equivalent on February 23, 1993, 119 days after the submission was received.
What is the product code of K925416?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.