Data / Medical devices / Japan / Top Corporation
Top Corporation: FDA-registered device maker in ADACHI-KU Tokyo, Japan, 6 510(k) clearances
Top Corporation is registered with the FDA (registration 9610993) in ADACHI-KU Tokyo, Japan. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 7, 1984. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610993
- FEI number
- 3002808374
- Address
- 19-10 Senju, Nakai-Cho, ADACHI-KU Tokyo, Japan, 120-0035
- Owner or operator
- TOP CORPORATION (8030272)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- March 2, 2008
- Registered through
- 2026
- Brand names listed
- Glass Syringe Lock 10 mL ISO neuraxial, Glass Syringe Lock 5 mL ISO neuraxial, Glass Syringe Slip 10 mL ISO neuraxial, Glass Syringe Slip 5 mL ISO neuraxial, NRFit Syringe, SYRINGE, TOP DISPOSABLE INFUSION SET, TOP DISPOSABLE PLASTIC SYRINGES and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anesthesia Conduction Kit | CAZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 2 | Manufacturer | accessdata.fda.gov |
| Patient Personal Hygiene Kit | NSB | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 7, 1984 | K843415 | TOP HYPODERMIC SYRINGE LUER LOCK | FMF | Substantially Equivalent | Top Surgical Manufacturers Co. | accessdata.fda.gov |
| September 19, 1984 | K843313 | TOP DISPOSABLE SPINAL NEEDLE | BSP | Substantially Equivalent | Top Surgical Manufacturers Co. | accessdata.fda.gov |
| September 7, 1984 | K843414 | TOP HYPODERMIC SYRINGE PISTON | FMF | Substantially Equivalent | Top Surgical Manufacturers Co. | accessdata.fda.gov |
| March 30, 1984 | K841025 | TOP DISPOSABLE INFUSION SET | FPA | Substantially Equivalent | Top Surgical Manufacturers Co. | accessdata.fda.gov |
| October 14, 1983 | K832622 | WINGED INFUSION SET | FPA | Substantially Equivalent | Top Surgical Manufacturers Co. | accessdata.fda.gov |
| October 14, 1983 | K832621 | TOP DISPOSABLE PLASTIC SYRINGES | FMF | Substantially Equivalent | Top Surgical Manufacturers Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Anesthesia Conduction Kit
- All makers of Set, Administration, Intravascular
- All makers of Syringe, Piston
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
- All makers of Patient Personal Hygiene Kit
Updated December 7, 1984. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.