MIST ENDOSCOPIC NEEDLES— 510(k) K951648
Substantially EquivalentMist, Inc.
FDA 510(k) clearance K951648 for MIST ENDOSCOPIC NEEDLES, Substantially Equivalent on 1995-05-12. Applicant: Mist, Inc.. Device class: 2.
Clearance details
- Applicant
- Mist, 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
- Great Neck, NY, US
Recent devices under product code FBK
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- K952323 — MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES
- K951480 — MIST TROCARS
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.