INSIDE VIEW— 510(k) K001217
Substantially EquivalentMonadnock Optics, Inc.
FDA 510(k) clearance K001217 for INSIDE VIEW, Substantially Equivalent on 2000-07-11. Applicant: Monadnock Optics, Inc.. Device class: 2.
Clearance details
- Applicant
- Monadnock Optics, Inc.
- Product code
- Code GCM
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huntingdon Valley, PA, US
Recent devices under product code GCM
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- K083840 — MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
- K993103 — ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES
- K993445 — OMNISONIC ENDOSCOPIC DEFLECTOR
- K962393 — KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION
Adverse events under product code GCM
product code GCM- Malfunction
- 1,233
- Total
- 1,233
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.