Manan Pediatric Bone Marrow Access Needle
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K962001 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Manan Pediatric Bone Marrow Access Needle is a medical device designed to provide access to the bone marrow for clinical procedures. It is categorized under product code FMI for use in general hospital settings.
This device has received FDA 510(k) clearance under submission number K962001. It is manufactured by Manan Medical Products, Inc. and is subject to the regulatory requirements associated with its traditional clearance type.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE (K962001) — FDA 510(k ..., PDF K962001 - Manan Pediatric Bone Marrow Access Needle, Device Listing 1899591955 - FDA.report, MANAN MEDICAL PRODUCTS, INC. FDA Filings - FDA.report, Manan Medical Products, Inc. - FDA 510 (k) Cleared Devices
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K962001 | Class II | Active |
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Manufacturer
- Manufacturer
- Manan Medical Products, Inc.
Sources (1)
- FDA 510(k) K962001 24 fields · synced Sep 27, 2026