MODIFICATION TO TEMNO BIOPSY NEEDLES— 510(k) K024120
Substantially EquivalentAllegiance Healthcare Corp.
FDA 510(k) clearance K024120 for MODIFICATION TO TEMNO BIOPSY NEEDLES, Substantially Equivalent on 2003-01-15. Applicant: Allegiance Healthcare Corp.. Device class: 2.
Clearance details
- Applicant
- Allegiance Healthcare Corp.
- Product code
- Code FCG
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mcgaw Park, IL, US
Recent devices under product code FCG
view allMore clearances from Allegiance Healthcare Corp.
view all- K023673 — AIRLIFE DEMAND NASAL CANNULA
- K023419 — TRILAMINATE DRAPES/TIBURON
- K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
- K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
- K023425 — DRAPES WITH ABSORBENT REINFORCEMENT
Adverse events under product code FCG
product code FCG- Death
- 13
- Injury
- 576
- Malfunction
- 1,966
- Total
- 2,555
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.