TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE— 510(k) K935834
Substantially EquivalentTechnology Marketing Group
FDA 510(k) clearance K935834 for TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE, Substantially Equivalent on 1994-03-07. Applicant: Technology Marketing Group. Device class: 2.
Clearance details
- Applicant
- Technology Marketing Group
- Product code
- Code FBN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maywood, NJ, US
Recent devices under product code FBN
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- K251170 — Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
- K243535 — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
More clearances from Technology Marketing Group
view allAdverse events under product code FBN
product code FBN- Death
- 8
- Malfunction
- 951
- Total
- 959
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.