FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOP STERILE DISPOS. HYPODERMIC NEEDLES
K Number: K832626
·
Decision Oct 14, 1983
Classifications
1
FEI Numbers
321
Registration Numbers
322
Same Product Code
106
Applicant Total
12
Review Days
71
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TOP STERILE DISPOS. HYPODERMIC NEEDLES
- K Number
- K832626
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Top Surgical Manufacturers Co.
- Date Received
- August 4, 1983
- Decision Date
- October 14, 1983
- Product Code
- GAA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAA | Needle, Aspiration And Injection, Disposable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAA), ordered by most recent decision date.
CapnoSpot Pneumothorax Decompression Indicator
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MANAN ACCURA NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K843313 | TOP DISPOSABLE SPINAL NEEDLE | Sep 19, 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 |
| K832622 | WINGED INFUSION SET | Oct 14, 1983 | Substantially Equivalent |
| K832621 | TOP DISPOSABLE PLASTIC SYRINGES | Oct 14, 1983 | Substantially Equivalent |