Sun Medical Co., Ltd.
Moriyama Shiga, JP
SUN MEDICAL CO., LTD. appears in FDA device records in Moriyama Shiga, JP. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Sun Medical Co., Ltd. between 1985 and 2015. The busiest year on record is 2015, with 2. The most recent is 2015, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1988 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 2015 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K150511 | Coating Material | EBI | Substantially Equivalent | |
| K143265 | Acrylic Block | EBI | Substantially Equivalent | |
| K921963 | DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 | HIF | Substantially Equivalent | |
| K911154 | SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 | FYD | Substantially Equivalent | |
| K874948 | SUN MEDICAL SMOKE EVACUATOR SYSTEM | GEX | Substantially Equivalent | |
| K845006 | SUN MEDICAL LAMINARIA CERVICAL DILATOR | HDY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8030419 | 3002973484 | SUN MEDICAL CO., LTD. | 571-2 Furutaka-cho, Moriyama Shiga 524-0044 JP | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain