BIOTEQ Drainage Catheter Set (One Step Type)— 510(k) K200103
Substantially EquivalentBioteque Corporation
FDA 510(k) clearance K200103 for BIOTEQ Drainage Catheter Set (One Step Type), Substantially Equivalent on 2020-10-09. Applicant: Bioteque Corporation. Device class: 2.
Clearance details
- Applicant
- Bioteque Corporation
- Product code
- Code FGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei City, TW
Recent devices under product code FGE
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- K253832 — Dilation Balloon Catheter
- K251658 — Endoflux Biliary & Pancreatic Stent Sets
- K253987 — BARE Wireguided Balloon Dilation Catheter (1235)
More clearances from Bioteque Corporation
view allAdverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
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.