The following data is part of a premarket notification filed by Gynetech Pty. Ltd. with the FDA for Insufflator Needle.
| Device ID | K142700 |
| 510k Number | K142700 |
| Device Name: | InsufflatOR Needle |
| Classification | Insufflator, Laparoscopic |
| Applicant | GYNETECH PTY. LTD. Unit 7, 6-8 Macquarie Drive Thomastown, AU 3095 |
| Contact | Kevin Macdonald |
| Correspondent | Kevin Macdonald MacDonald Consulting 229 Marvilla Circle Pacifica, CA 94044 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-22 |
| Decision Date | 2014-12-19 |
| Summary: | summary |