SERIES 400 GASTROENTEROLOGY SYSTEM— 510(k) K944620
Substantially EquivalentMarks & Murase
FDA 510(k) clearance K944620 for SERIES 400 GASTROENTEROLOGY SYSTEM, Substantially Equivalent on 1995-04-27. Applicant: Marks & Murase. Device class: 2.
Clearance details
- Applicant
- Marks & Murase
- Product code
- Code FET
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code FET
view allMore clearances from Marks & Murase
view allAdverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
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 K944620
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 K944620.
Data sourced from openFDA. This site is unofficial and independent of the FDA.