TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG— 510(k) K852680
Substantially EquivalentMultigon Industries, Inc.
FDA 510(k) clearance K852680 for TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG, Substantially Equivalent on 1985-12-23. Applicant: Multigon Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Multigon Industries, Inc.
- Product code
- Code HET
- Device class
- Class 2
- Regulation
- 21 CFR 884.1720
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mt. Vernon, NY, US
Recent devices under product code HET
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- K912044 — MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
- K881263 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
- K882755 — MODEL 500V VASCULAR SPECTRUM ANALYZER
Adverse events under product code HET
product code HET- Malfunction
- 10,504
- Total
- 10,504
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.