FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SABRESOURCE DRAPE
K Number: K041846
·
Decision Aug 26, 2004
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
14
Review Days
49
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Basic Information
- Device Name
- SABRESOURCE DRAPE
- K Number
- K041846
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Minrad, Inc.
- Date Received
- July 8, 2004
- Decision Date
- August 26, 2004
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | 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 |
| K021084 | LIGHT SABER SPINAL NEEDLE | Jul 3, 2002 | Substantially Equivalent |
| K013040 | LIGHT SABER INTRODUCER NEEDLE | Dec 7, 2001 | 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 |