FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIGHT SABER INTRODUCER NEEDLE
K Number: K013040
·
Decision Dec 7, 2001
Classifications
1
FEI Numbers
840
Registration Numbers
840
Same Product Code
43
Applicant Total
14
Review Days
88
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Basic Information
- Device Name
- LIGHT SABER INTRODUCER NEEDLE
- K Number
- K013040
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Minrad, Inc.
- Date Received
- September 10, 2001
- Decision Date
- December 7, 2001
- Product Code
- MDM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Minrad, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072255 | MINRAD INC. NASAL SCAVENGING CIRCUIT | Oct 18, 2007 | Substantially Equivalent |
| K071814 | LIGHT SABRE SPINAL ACCESS DEVICE | Oct 16, 2007 | Substantially Equivalent |
| K062231 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 | Aug 31, 2006 | Substantially Equivalent |
| K062230 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 | Aug 31, 2006 | Substantially Equivalent |
| K041852 | MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 | Nov 15, 2004 | Substantially Equivalent |
| K041846 | SABRESOURCE DRAPE | Aug 26, 2004 | Substantially Equivalent |
| K021084 | LIGHT SABER SPINAL NEEDLE | Jul 3, 2002 | Substantially Equivalent |
| K982735 | LIGHT SABER BONE BIOPSY NEEDLE | Sep 9, 1998 | Substantially Equivalent |
| K982018 | LIGHT SABER ASPIRATION NEEDLE | Aug 7, 1998 | Substantially Equivalent |
| K981796 | LIGHT SABER CORE TISSUE NEEDLE | Aug 5, 1998 | Substantially Equivalent |