FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOP DISPOSABLE SPINAL NEEDLE
K Number: K843313
·
Decision Sep 19, 1984
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
12
Review Days
26
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Basic Information
- Device Name
- TOP DISPOSABLE SPINAL NEEDLE
- K Number
- K843313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Top Surgical Manufacturers Co.
- Date Received
- August 24, 1984
- Decision Date
- September 19, 1984
- 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 Top Surgical Manufacturers Co.
| K Number | Device Name | ||
|---|---|---|---|
| K844343 | TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE | Jan 8, 1985 | Substantially Equivalent |
| K843415 | TOP HYPODERMIC SYRINGE LUER LOCK | Dec 7, 1984 | Substantially Equivalent |
| K843414 | TOP HYPODERMIC SYRINGE PISTON | Sep 7, 1984 | Substantially Equivalent |
| K841119 | TOPS DISPOS. INFUSION SET/HEMODIALYSIS | Apr 20, 1984 | Substantially Equivalent |
| K841025 | TOP DISPOSABLE INFUSION SET | Mar 30, 1984 | Substantially Equivalent |
| K832624 | TOP VENULA I.V. CATHETER SET | Nov 21, 1983 | Substantially Equivalent |
| K832625 | TOP THREE WAY STOPCOCK | Oct 19, 1983 | Substantially Equivalent |
| K832626 | TOP STERILE DISPOS. HYPODERMIC NEEDLES | Oct 14, 1983 | Substantially Equivalent |
| K832622 | WINGED INFUSION SET | Oct 14, 1983 | Substantially Equivalent |
| K832621 | TOP DISPOSABLE PLASTIC SYRINGES | Oct 14, 1983 | Substantially Equivalent |