The following data is part of a premarket notification filed by Unimicro Medical Systems (shenzhen) Co., Ltd. with the FDA for Unimicro Trocar Kit, Models: Auto-locking Trocar, Hasson Trocar, Bladeless Trocar.
| Device ID | K141594 |
| 510k Number | K141594 |
| Device Name: | Unimicro Trocar Kit, Models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar |
| 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 | 2015-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810143450644 | K141594 | 000 |
| 00810143450453 | K141594 | 000 |
| 00810143450392 | K141594 | 000 |
| 00810143450279 | K141594 | 000 |