ShinChang Medical Co., Ltd.
Gumi-si Gyeongbuk, KR
SHINCHANG MEDICAL CO., LTD. appears in FDA device records in Gumi-si Gyeongbuk, KR. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for ShinChang Medical Co., Ltd. between 2000 and 2007. The busiest year on record is 2007, with 2. The most recent is 2007, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2007 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K071382 | SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77, | FOZ | Substantially Equivalent | |
| K070988 | SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) | FMI | Substantially Equivalent | |
| K993017 | PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE | FMF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9616157 | 3003169040 | SHINCHANG MEDICAL CO., LTD. | 144, 1gongdan-ro 6-gil, Gumi-si Gyeongbuk 39385 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3202-2018 | Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.) | Defect consists of a small crack in the top end of the barrel near the needle. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain