MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE— 510(k) K944837
Substantially EquivalentMedical Device Technologies, Inc.
FDA 510(k) clearance K944837 for MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE, Substantially Equivalent on 1994-10-14. 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.