Insufflator (OPTO-IFL1000)— 510(k) K231342
Substantially EquivalentGuangdong Optomedic Technologies, Inc.
FDA 510(k) clearance K231342 for Insufflator (OPTO-IFL1000), Substantially Equivalent on 2023-09-20. Applicant: Guangdong Optomedic Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Guangdong Optomedic Technologies, Inc.
- Product code
- 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 all- K252697 — 3D Laparoscope
- K242513 — FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
- K241530 — Stellar Imaging System
- K230407 — FloNavi Open Field Fluorescence Imaging System
- K231003 — Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
Adverse 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.