The following data is part of a premarket notification filed by Unimax Medical Systems Inc. with the FDA for Softfix Balloon Trocar.
| Device ID | K211577 |
| 510k Number | K211577 |
| Device Name: | SoftFix Balloon Trocar |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Unimax Medical Systems Inc. 8F-2, No. 127, Lane 235, Pao Chiao Road New Taipei, TW 23145a |
| Contact | Monoj Mon Kalita |
| Correspondent | Monoj Mon Kalita Unimax Medical Systems Inc. 8F-2, No. 127, Lane 235, Pao Chiao Road New Taipei, TW 23145a |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-21 |
| Decision Date | 2021-11-05 |