CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI— 510(k) K924530
Substantially EquivalentCabot Medical Corp.
FDA 510(k) clearance K924530 for CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI, Substantially Equivalent on 1993-02-05. Applicant: Cabot Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Cabot Medical Corp.
- 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
- Langhorne, PA, US
Recent devices under product code HET
view allMore clearances from Cabot Medical Corp.
view all- K960148 — CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT
- K946109 — CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS
- K951972 — CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS
- K951714 — CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER
- K941743 — CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
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.