16 Ga X 6 Bullet Point Needle
FDA 510(k) K894872 · R. J. Doyle, Inc.
510(k) numberK894872
Submission
- Device name
- 16 Ga X 6 Bullet Point Needle
- Applicant
- R. J. Doyle, Inc.
Spirit Lake, ID, US - Received
- August 1, 1989
- Decision date
- September 22, 1989
- 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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|---|---|---|---|
| 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 |
| 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 |
More from Manan Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K894882 | Infiltration Pump SyringeBSP · Traditional | 11/30/1989SE |
| K894881 | 20GA X 7-1/2 Threading Bullet Point NeedleBSP · Traditional | 11/30/1989SE |
| K894880 | 16GA X 14 Fourteen Long Long Bullet Point NeedlBSP · Traditional | 11/30/1989SE |
| K894879 | 16GA X 10 Middle Size Bullet Point NeedleBSP · Traditional | 11/30/1989SE |
| K894878 | 16GA X 6 Bullet Point Needle, Flex Stainless SteeBSP · Traditional | 11/30/1989SE |
| K894875 | 20GA X 7-1/2 Threading Bullet Point NeedleGAA · Traditional | 09/22/1989SE |
| K894874 | 14 Inch Bullet Point NeedleGAA · Traditional | 09/22/1989SE |
| K894873 | 16 Ga X 10 Bullet Point NeedleGAA · Traditional | 09/22/1989SE |
| K872200 | Hamacher Bullet Point Ophthalmic NeedleHMX · Traditional | 06/25/1987SE |
Questions and answers
When was 16 Ga X 6 Bullet Point Needle cleared by the FDA?
16 Ga X 6 Bullet Point Needle (K894872) received a 510(k) decision of Substantially Equivalent on September 22, 1989, 52 days after the submission was received.
What is the product code of K894872?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.