K193339 is an FDA 510(k) clearance for the GTK Veress Needles. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Guangzhou T.K Medical Instrument Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on January 30, 2020, 59 days after receiving the submission on December 2, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K193339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2019 |
| Decision Date | January 30, 2020 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIF - Insufflator, Laparoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1730 |