The following data is part of a premarket notification filed by Neosurgical Ltd with the FDA for Neoclose Pds.
| Device ID | K173917 |
| 510k Number | K173917 |
| Device Name: | NeoClose PDS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | neoSurgical Ltd Block 12, Galway Technology Park Galway, IE H91 E4yd |
| Contact | Orla Brennan |
| Correspondent | Orla Brennan neoSurgical Ltd Block 12, Galway Technology Park Galway, IE H91 E4yd |
| Product Code | GCJ |
| Subsequent Product Code | GAR |
| Subsequent Product Code | GDW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-22 |
| Decision Date | 2018-11-08 |
| Summary: | summary |