N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE— 510(k) K983218
Substantially EquivalentAvid N.I.T., Inc.
FDA 510(k) clearance K983218 for N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE, Substantially Equivalent on 1998-11-06. Applicant: Avid N.I.T., Inc.. Device class: 2.
Clearance details
- Applicant
- Avid N.I.T., Inc.
- 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
- Traditional
- Location
- Oldsmar, FL, US
Recent devices under product code FCG
view allMore clearances from Avid N.I.T., Inc.
view all- K014246 — AVID-NIT NERVE STIMULATION NEEDLES
- K013231 — AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L
- K972595 — ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
- K972554 — REGANES RADIONUCLIDE SEED MAGAZINE
- K973037 — N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
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.