Light Saber Spinal Needle
FDA 510(k) K021084 · Minrad, Inc.
510(k) numberK021084
Submission
- Device name
- Light Saber Spinal Needle
- Applicant
- Minrad, Inc.
Buffalo, NY, US - Received
- April 4, 2002
- Decision date
- July 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
Other 510(k)s with product code FMF
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|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K260208 | Ultra-Fine SAFETY Insulin SyringeFMF · Traditional | embecta Medical II, LLC | 07/13/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/18/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | CMT Health PTE., Ltd. | 06/12/2026SE |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 05/21/2026SE |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
More from Instylla, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K072255 | Minrad Inc. Nasal Scavenging CircuitCBN · Traditional | 10/18/2007SE |
| K071814 | Light Sabre Spinal Access DeviceKNW · Traditional | 10/16/2007SE |
| K062231 | MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001CCW · Special | 08/31/2006SE |
| K062230 | MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002CCW · Special | 08/31/2006SE |
| K041852 | MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002CCW · Traditional | 11/15/2004SE |
| K041846 | Sabresource DrapeKKX · Traditional | 08/26/2004SE |
| K013040 | Light Saber Introducer NeedleMDM · Traditional | 12/07/2001SE |
| K982735 | Light Saber Bone Biopsy NeedleKNW · Traditional | 09/09/1998SE |
| K982018 | Light Saber Aspiration NeedleFMF · Traditional | 08/07/1998SE |
| K981796 | Light Saber Core Tissue NeedleKNW · Traditional | 08/05/1998SE |
Questions and answers
When was Light Saber Spinal Needle cleared by the FDA?
Light Saber Spinal Needle (K021084) received a 510(k) decision of Substantially Equivalent on July 3, 2002, 90 days after the submission was received.
What is the product code of K021084?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.