FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GRIESHABER AIR/FLUID TUBING SET
K Number: K914587
·
Decision Jan 23, 1992
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
39
Applicant Total
15
Review Days
99
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Basic Information
- Device Name
- GRIESHABER AIR/FLUID TUBING SET
- K Number
- K914587
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4360
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Grieshaber & Co.
- Date Received
- October 16, 1991
- Decision Date
- January 23, 1992
- Product Code
- KYG
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | FDA class 1 | Ophthalmic |
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Other Clearances by Grieshaber & Co.
| K Number | Device Name | ||
|---|---|---|---|
| K950056 | THE GRIESHABER AXIAL CUTTER | May 5, 1995 | Substantially Equivalent |
| K930842 | THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE | May 3, 1994 | Substantially Equivalent |
| K914588 | GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE | Jun 11, 1992 | Substantially Equivalent |
| K914585 | GRIESHABER TWO FUNCTION MANIPULATOR | Jan 3, 1992 | Substantially Equivalent |
| K914586 | GRIESHABER THREE FUNCTION MANIPULATOR | Jan 3, 1992 | Substantially Equivalent |
| K897119 | GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP | Apr 12, 1990 | Substantially Equivalent |
| K900714 | ZZIPP INSTANT BOVIE CLEANER | Mar 27, 1990 | Substantially Equivalent |
| K890782 | GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) | Jun 23, 1989 | Substantially Equivalent |
| K890783 | GRIESHABER VISCOELASTIC INJECTION SYSTEM | May 16, 1989 | Substantially Equivalent |
| K884043 | GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE | Nov 16, 1988 | Substantially Equivalent |