ULTRACLIP TISSUE MARKER— 510(k) K993785
Substantially EquivalentInrad
FDA 510(k) clearance K993785 for ULTRACLIP TISSUE MARKER, Substantially Equivalent on 2000-02-04. Applicant: Inrad. Device class: 2.
Clearance details
- Applicant
- Inrad
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kentwood, MI, US
Recent devices under product code GDW
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 GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
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 →
Recalls naming K993785
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993785.
Data sourced from openFDA. This site is unofficial and independent of the FDA.