Manan Brest Tumor Localization Needle
FDA 510(k) K863848 · Manan Manufacturing Co., Inc.
510(k) numberK863848
Submission
- Device name
- Manan Brest Tumor Localization Needle
- Applicant
- Manan Manufacturing Co., Inc.
Skokie, IL, US - Received
- September 30, 1986
- Decision date
- October 14, 1986
- 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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| 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 |
|---|---|---|
| K873208 | Manan Turner Style NeedleKNW · Traditional | 08/25/1987SE |
| K864405 | Manan Contrast Media Administration SetFPA · Traditional | 12/18/1986SE |
| K852501 | Myelogram Procedure Tray · Traditional | 07/11/1985SESD |
| K852018 | Arthrogram Tray for Double & Single Contrast Arthr · Traditional | 07/11/1985SESD |
| K851834 | Manan Gwi Guide Wire IntroducerDWS · Traditional | 07/11/1985SE |
| K851833 | Manan Seldinger NeedleDWS · Traditional | 07/11/1985SE |
| K851832 | Naman Potts Cournand NeedleDWS · Traditional | 07/11/1985SE |
| K852428 | Manan Epidural NeedleGCB · Traditional | 06/27/1985SE |
| K852427 | Manan Spinal NeedleGAA · Traditional | 06/27/1985SE |
| K852426 | Manan Trocar Style Biopsy NeedleGAA · Traditional | 06/27/1985SE |
Questions and answers
When was Manan Brest Tumor Localization Needle cleared by the FDA?
Manan Brest Tumor Localization Needle (K863848) received a 510(k) decision of Substantially Equivalent on October 14, 1986, 14 days after the submission was received.
What is the product code of K863848?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.