Insufflator (OPTO-IFL1000)— 510(k) K252318
Substantially EquivalentGuangdong Optomedic Technologies, Inc.
FDA 510(k) clearance K252318 for Insufflator (OPTO-IFL1000), Substantially Equivalent on 2026-04-16. Applicant: Guangdong Optomedic Technologies, Inc.. Device class: 2.
Summary
Guangdong Optomedic Technologies' Insufflator (model OPTO-IFL1000) is filed under product code HIF (Insufflator, Laparoscopic). The name is generic.
Class II, 21 CFR 884.1730. It came in as a Traditional 510(k), and Obstetrics/Gynecology is both the classification panel and the review panel.
Guangdong Optomedic Technologies filed from Foshan, China. Review took 265 calendar days (July 25, 2025 to April 16, 2026).
Clearance details
- Applicant
- Guangdong Optomedic Technologies, Inc.
- Product code
- Product code HIF
- Device class
- Class 2
- Regulation
- 21 CFR 884.1730
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foshan, CN
Recent devices under product code HIF
view allMore clearances from Guangdong Optomedic Technologies, Inc.
view allAdverse events under product code HIF
product code HIF- Death
- 19
- Injury
- 578
- Malfunction
- 5,639
- Total
- 6,236
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.