K231342 is an FDA 510(k) clearance for the Insufflator (OPTO-IFL1000). This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Guangdong Optomedic Technologies, Inc. (Foshan, CN). The FDA issued a Cleared decision on September 20, 2023, 134 days after receiving the submission on May 9, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K231342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2023 |
| Decision Date | September 20, 2023 |
| Days to Decision | 134 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 |