Light Sabre Spinal Access Device
FDA 510(k) K071814 · Minrad, Inc.
510(k) numberK071814
Submission
- Device name
- Light Sabre Spinal Access Device
- Applicant
- Minrad, Inc.
Orchard Park, NY, US - Received
- July 2, 2007
- Decision date
- October 16, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Light Sabre Spinal Access Device cleared by the FDA?
Light Sabre Spinal Access Device (K071814) received a 510(k) decision of Substantially Equivalent on October 16, 2007, 106 days after the submission was received.
What is the product code of K071814?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.