Manan Pediatric Bone Marrow Access Needle
FDA 510(k) K962001 · Manan Medical Products, Inc.
510(k) numberK962001
Submission
- Device name
- Manan Pediatric Bone Marrow Access Needle
- Applicant
- Manan Medical Products, Inc.
Northbrook, IL, US - Received
- May 22, 1996
- Decision date
- January 10, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
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| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K052802 | Manan Bio-Cut Soft Tissue Biopsy NeedleKNW · Special | 11/01/2005SE |
| K011209 | Manan Spritacre Spinal NeedlesBSP · Traditional | 06/26/2001SE |
| K983620 | Manan Spinal NeedlesBSP · Traditional | 01/08/1999SE |
| K980536 | Epidural NeedleBSP · Traditional | 07/31/1998SE |
| K981386 | Manan Blunt NeedleFPA · Traditional | 06/29/1998SE |
| K980211 | MRI Chiba,Spinal,Breast Localization,Automatic Cutting NeedlesKNW · Traditional | 02/06/1998SE |
| K974446 | Manan Automatic Cutting NeedleKNW · Traditional | 01/08/1998SE |
| K962977 | MRI Compatible Biopsy NeedlesKNW · Traditional | 10/09/1997SE |
| K963767 | Manan V.S. Access Needle/SetFGE · Traditional | 05/16/1997SE |
| K961986 | Manan D BagEXF · Traditional | 03/13/1997SE |
Questions and answers
When was Manan Pediatric Bone Marrow Access Needle cleared by the FDA?
Manan Pediatric Bone Marrow Access Needle (K962001) received a 510(k) decision of Substantially Equivalent on January 10, 1997, 233 days after the submission was received.
What is the product code of K962001?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.