Data / Medical devices / Japan / Kobayashi Shoji K.K.
Kobayashi Shoji K.K.: FDA-registered device maker in Kitasaiwai, Nishi-Ku, Yokohama Kanagawa, Japan, 6 510(k) clearances
Kobayashi Shoji K.K. is registered with the FDA (registration 9614747) in Kitasaiwai, Nishi-Ku, Yokohama Kanagawa, Japan. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 6, 2016. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9614747
- FEI number
- 3001738911
- Address
- NMF Yokohama Nishiguchi Bldg. No. 11-11, 1-Chome, Kitasaiwai, Nishi-Ku, Yokohama Kanagawa, Japan, 220-0004
- Owner or operator
- KOBAYASHI SHOJI K.K. (9038953)
- Roles
- Exporter to the US
- First device listed
- January 20, 2008
- Registered through
- 2026
- Brand names listed
- MYCO Medical, phoenix
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Vascular | DXC | 2 | Exporter to the US | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 2 | Exporter to the US | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Exporter to the US | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| September 6, 2016 | K160269 | Surgical Face Masks (Ear loops and Tie-on) | FXX | Substantially Equivalent | San-M Package Co., Ltd. | accessdata.fda.gov |
| August 18, 2016 | K161315 | Vein Clamps, Artery Clamps | DXC | Substantially Equivalent | Aros Surgical Instruments Corporation | accessdata.fda.gov |
| July 15, 2016 | K160271 | N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 | MSH | Substantially Equivalent | San-M Package Co., Ltd. | accessdata.fda.gov |
| October 14, 2004 | K042367 | NYLON THREADED NEEDLE | GAR | Substantially Equivalent | Aros Surgical Instruments Corp. | accessdata.fda.gov |
| June 2, 2000 | K990519 | PHOENIX EPIDURAL & SPINAL NEEDLES | BSP | Substantially Equivalent | Myco Medical Supplies, Inc. | accessdata.fda.gov |
| June 19, 1996 | K961100 | MICRO ANASTOMOSIS CLAMP | DXC | Substantially Equivalent | R.S.P. Medical Management, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Clamp, Vascular
- All makers of Suture, Nonabsorbable, Synthetic, Polyamide
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
- All makers of Mask, Surgical
- All makers of Respirator, Surgical
Updated September 6, 2016. 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.