Namic Chiba Aspiration Biopsy Needle
FDA 510(k) K864800 · North American Instrument Corp.
510(k) numberK864800
Submission
- Device name
- Namic Chiba Aspiration Biopsy Needle
- Applicant
- North American Instrument Corp.
Glens Falls, NY, US - Received
- December 9, 1986
- Decision date
- February 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K011586 | Irma SL Blood Analysis System GL CartridgeGAA · Traditional | Diametrics Medical, Inc. | 11/16/2001SE |
| K994151 | Percutx-Injection/Aspiration Needle Probes/DevicesGAA · Traditional | Ximed/Prosure/Injectx | 03/01/2000SE |
| 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 |
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| K922552 | Morse(R) Angiographic CathetersDQO · Traditional | 03/03/1993SE |
| K915078 | Morse Hemostatic Catheter Introducer SetDYB · Traditional | 06/10/1992SE |
| K905208 | Morse AnesthesiaFPA · Traditional | 01/10/1992SE |
| K912961 | Morse Vascular Introducer SetDYB · Traditional | 09/11/1991SE |
| K910764 | The Perceptor(Tm) Stand Alone TransducerDRS · Traditional | 04/22/1991SE |
| K903493 | Namic Contrast Savings Delivery SystemIZI · Traditional | 03/26/1991SE |
| K904275 | Morse Balloon Inflation DeviceMAV · Traditional | 01/03/1991SE |
Questions and answers
When was Namic Chiba Aspiration Biopsy Needle cleared by the FDA?
Namic Chiba Aspiration Biopsy Needle (K864800) received a 510(k) decision of Substantially Equivalent on February 6, 1987, 59 days after the submission was received.
What is the product code of K864800?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.