FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING
K Number: K910791
·
Decision May 17, 1991
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
66
Review Days
81
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Basic Information
- Device Name
- CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING
- K Number
- K910791
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
- Date Received
- February 25, 1991
- Decision Date
- May 17, 1991
- Product Code
- BSP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | FDA class 2 | Anesthesiology |
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Other Clearances by Kendall Healthcare Products Co. Div.Of Tyco Health
| K Number | Device Name | ||
|---|---|---|---|
| K973763 | KENDALL CURITY IODOFORM PACKING STRIP | Dec 31, 1997 | Substantially Equivalent |
| K973511 | KENDALL CURITY PETROLATUM GAUZE | Dec 16, 1997 | Substantially Equivalent for Some Indications |
| K973507 | KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) | Dec 15, 1997 | Substantially Equivalent for Some Indications |
| K973619 | KENDALL CURITY NON-ADHERING DRESSING | Dec 10, 1997 | Substantially Equivalent for Some Indications |
| K973509 | KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING | Dec 4, 1997 | Substantially Equivalent for Some Indications |
| K973546 | KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER | Nov 7, 1997 | Substantially Equivalent |
| K970266 | KENDALL HYDROPHILIC POWDER WOUND DRESSING | Apr 23, 1997 | Substantially Equivalent for Some Indications |
| K963446 | KENDALL DUAL LUMEN CATHETER | Mar 18, 1997 | Substantially Equivalent |
| K964899 | KENDALL CURITY URETERAL CATHETER | Feb 7, 1997 | Substantially Equivalent |
| K964519 | CURITY THORACENTESIS TRAY | Dec 20, 1996 | Substantially Equivalent |