MIST ENDOSCOPIC CANNULAS— 510(k) K951481
Substantially EquivalentMist, Inc.
FDA 510(k) clearance K951481 for MIST ENDOSCOPIC CANNULAS, Substantially Equivalent on 1995-05-03. Applicant: Mist, Inc.. Device class: 2.
Clearance details
- Applicant
- Mist, Inc.
- Product code
- Code GCJ
- 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 GCJ
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- K260884 — UNIDRIVE Select System
- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from Mist, Inc.
view all- K970937 — MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM)
- K971150 — MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE
- K952290 — MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES
- K952323 — MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES
- K951648 — MIST ENDOSCOPIC NEEDLES
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.