Light Saber Introducer Needle
FDA 510(k) K013040 · Minrad, Inc.
510(k) numberK013040
Submission
- Device name
- Light Saber Introducer Needle
- Applicant
- Minrad, Inc.
Washington, DC, US - Received
- September 10, 2001
- Decision date
- December 7, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K073664 | Frontline Medical Safetynet Guidewire IntroducerMDM · Traditional | Injectimed, Inc. | 08/08/2008SE |
| K050575 | Futumeds No Patient Contact Safety Lancet with Pals SystemMDM · Traditional | Futumeds Sdn Bhd | 08/15/2005SE |
| K050957 | EutrocharMDM · Traditional | Special Devices, Inc. | 05/18/2005SE |
| K023173 | Andrews Introducer, Model ASI01MDM · Traditional | Andrews Surgical Innovations, Ltd. | 12/18/2002SE |
| K022059 | Microvasive Pulmonary GuidewireMDM · Traditional | Boston Scientific Corp | 11/13/2002SE |
| K010184 | Chess Hand Surgery SystemMDM · Traditional | Canica Design, Inc. | 06/22/2001SE |
| K990062 | SaphliftMDM · Traditional | Genzyme Surgical Product (Genzyme Biosurgery) | 03/30/1999SE |
| K981579 | Endopouch Pro Specimen Retrieval BagMDM · Traditional | ETHICON, Inc. | 07/09/1998SE |
| K943968 | TunnelerMDM · Traditional | Denver Biomedicals, Inc. | 03/01/1995SE |
| K945430 | Dermavblade(Tm)MDM · Traditional | Hasting'S Biomedical Corp. | 11/28/1994SE |
More from Hasting'S Biomedical Corp.
| 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 |
| K021084 | Light Saber Spinal NeedleFMF · Traditional | 07/03/2002SE |
| 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 Introducer Needle cleared by the FDA?
Light Saber Introducer Needle (K013040) received a 510(k) decision of Substantially Equivalent on December 7, 2001, 88 days after the submission was received.
What is the product code of K013040?
The FDA product code is MDM – Instrument, Manual, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.