HYSTEROFLATOR 2001— 510(k) K895907
Substantially EquivalentCabot Medical Corp.
FDA 510(k) clearance K895907 for HYSTEROFLATOR 2001, Substantially Equivalent on 1989-12-14. Applicant: Cabot Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Cabot Medical Corp.
- Product code
- Code HIG
- Device class
- Class 2
- Regulation
- 21 CFR 884.1700
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Langhorne, PA, US
Recent devices under product code HIG
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 HIG
product code HIG- Death
- 8
- Other
- 2
- Total
- 10
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.