3000 ELECTRONIC INSUFFLATOR MODIFICATION— 510(k) K934115
Substantially EquivalentCabot Medical Corp.
FDA 510(k) clearance K934115 for 3000 ELECTRONIC INSUFFLATOR MODIFICATION, Substantially Equivalent on 1995-03-15. Applicant: Cabot Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Cabot Medical Corp.
- 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
- Langhorne, PA, US
Recent devices under product code HIF
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- K951714 — CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER
- K941743 — CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
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.