Top Surgical Manufacturers Co.
Walker, MI, US
Top Surgical Manufacturers Co. appears in FDA device records in Walker, MI. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Top Surgical Manufacturers Co. between 1983 and 1985. The busiest year on record is 1983, with 6. The most recent is 1985, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 6 |
| 1984 | 5 |
| 1985 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K844343 | TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE | FIE | Substantially Equivalent | |
| K843415 | TOP HYPODERMIC SYRINGE LUER LOCK | FMF | Substantially Equivalent | |
| K843313 | TOP DISPOSABLE SPINAL NEEDLE | BSP | Substantially Equivalent | |
| K843414 | TOP HYPODERMIC SYRINGE PISTON | FMF | Substantially Equivalent | |
| K841119 | TOPS DISPOS. INFUSION SET/HEMODIALYSIS | KNZ | Substantially Equivalent | |
| K841025 | TOP DISPOSABLE INFUSION SET | FPA | Substantially Equivalent | |
| K832624 | TOP VENULA I.V. CATHETER SET | FOZ | Substantially Equivalent | |
| K832625 | TOP THREE WAY STOPCOCK | DTL | Substantially Equivalent | |
| K832626 | TOP STERILE DISPOS. HYPODERMIC NEEDLES | GAA | Substantially Equivalent | |
| K832623 | TOP DISPOS. INFUSION SET/HEMODIALY | KOC | Substantially Equivalent | |
| K832622 | WINGED INFUSION SET | FPA | Substantially Equivalent | |
| K832621 | TOP DISPOSABLE PLASTIC SYRINGES | FMF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNZAccessories, A-V Shunt
- KOCAccessories, Blood Circuit, Hemodialysis
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- GAANeedle, Aspiration And Injection, Disposable
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FIENeedle, Fistula
- FPASet, Administration, Intravascular
- FMFSyringe, Piston
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain