MANAN(TM) SUPER-CORE BIOPSY NEEDLES— 510(k) K974814
Substantially EquivalentMedical Device Technologies, Inc.
FDA 510(k) clearance K974814 for MANAN(TM) SUPER-CORE BIOPSY NEEDLES, Substantially Equivalent on 1998-01-09. Applicant: Medical Device Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Device Technologies, Inc.
- 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
- Gainsville, FL, US
Recent devices under product code KNW
view allMore clearances from Medical Device Technologies, Inc.
view all- K101832 — BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
- K053518 — INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
- K051421 — INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
- K050873 — CANALIZER HYDROPHILIC GUIDE WIRE
- K043523 — INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
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 →
Recalls naming K974814
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 K974814.
Data sourced from openFDA. This site is unofficial and independent of the FDA.