FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IRRIGATING BLUNT DISSECTOR
K Number: K931912
·
Decision Aug 10, 1993
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
40
Applicant Total
10
Review Days
116
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Basic Information
- Device Name
- IRRIGATING BLUNT DISSECTOR
- K Number
- K931912
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6960
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mayaguez Medical Center
- Date Received
- April 16, 1993
- Decision Date
- August 10, 1993
- Product Code
- KYZ
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KYZ | Syringe, Irrigating (Non Dental) | FDA class 1 | General Hospital |
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Other Clearances by Mayaguez Medical Center
| K Number | Device Name | ||
|---|---|---|---|
| K932804 | IRRIGATING TAPERED PROBE | Aug 16, 1993 | Substantially Equivalent |
| K932805 | 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT | Aug 16, 1993 | Substantially Equivalent |
| K931950 | POOLE TIP SUCTION PROBE | Aug 11, 1993 | Substantially Equivalent |
| K932806 | POOLE TIP SUCTION PROBE & TUBING KIT | Aug 11, 1993 | Substantially Equivalent |
| K931856 | 5.0 MM IRRIGATION/ASPIRATION PROBE | Aug 10, 1993 | Substantially Equivalent |
| K931854 | ENDOSCOPIC BLUNT DISSECTING INSTRUMENT | Aug 10, 1993 | Substantially Equivalent |
| K931707 | ENDOSCOPIC CABLE/WIRE COVER | Aug 6, 1993 | Substantially Equivalent |
| K931706 | ENDOSCOPIC CABLE DRAPE | Aug 6, 1993 | Substantially Equivalent |
| K931705 | ENDOSCOPIC INSTRUMENT HOLDER | Jul 22, 1993 | Substantially Equivalent |