The following data is part of a premarket notification filed by Lagis Enterprises Co, Ltd. with the FDA for Lagis Endoscopic Instruments Disposable Grasper.
| Device ID | K141902 |
| 510k Number | K141902 |
| Device Name: | LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LAGIS ENTERPRISES CO, LTD. NO. 29, GONG 1ST RD., DAJIA Taichung, TW 437 |
| Contact | Cora Chen |
| Correspondent | Cora Chen LAGIS ENTERPRISES CO, LTD. NO. 29, GONG 1ST RD., DAJIA Taichung, TW 437 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-14 |
| Decision Date | 2015-05-26 |
| Summary: | summary |