The following data is part of a premarket notification filed by Unimicro Medical Systems (shenzhen) Co., Ltd. with the FDA for Unimicro Disposable Retrieval Endo-pouch.
| Device ID | K141593 |
| 510k Number | K141593 |
| Device Name: | UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. R15-08, EAST BUILDING, YIHAI PLAZA, CHUANGYE ROADS, NANSHAN DISTRICT Shenzhen, Guangdong, CN 518054 |
| Contact | Long Yang |
| Correspondent | Long Yang UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. R15-08, EAST BUILDING, YIHAI PLAZA, CHUANGYE ROADS, NANSHAN DISTRICT Shenzhen, Guangdong, CN 518054 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-13 |
| Decision Date | 2014-11-13 |
| Summary: | summary |