ULTRACLIP II US— 510(k) K042341
Substantially EquivalentInrad
FDA 510(k) clearance K042341 for ULTRACLIP II US, Substantially Equivalent on 2004-09-20. Applicant: Inrad. Device class: 2.
Clearance details
- Applicant
- Inrad
- Product code
- Code NEU
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Kentwood, MI, US
Recent devices under product code NEU
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
- K041201 — ULTRACLIP II MR
Adverse events under product code NEU
product code NEU- Injury
- 824
- Total
- 824
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.