TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE— 510(k) K901437
Substantially EquivalentTelemed Systems, Inc.
FDA 510(k) clearance K901437 for TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE, Substantially Equivalent on 1990-06-18. Applicant: Telemed Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Telemed Systems, Inc.
- Product code
- Code FBK
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hudson, MA, US
Recent devices under product code FBK
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- K992402 — 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH
Adverse events under product code FBK
product code FBK- Other
- 1
- Total
- 1
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.