ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE— 510(k) K000612
Substantially EquivalentInrad
FDA 510(k) clearance K000612 for ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE, Substantially Equivalent on 2000-04-24. Applicant: Inrad. Device class: 2.
Clearance details
- Applicant
- Inrad
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kentwood, MI, US
Recent devices under product code KNW
view allMore clearances from Inrad
view all- K093399 — PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520
- K093256 — SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018
- K090611 — REVOLUTION FULL CORE BIOPSY
- K063238 — ULTRACLIP II WING AND ULTRACLIP II COIL
- K042341 — ULTRACLIP II US
Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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.