MODERN MEDICAL RESECTOSCOPE ELECTRODES— 510(k) K091511
Substantially EquivalentModern Medical Equipment Mfg., Ltd.
FDA 510(k) clearance K091511 for MODERN MEDICAL RESECTOSCOPE ELECTRODES, Substantially Equivalent on 2010-01-15. Applicant: Modern Medical Equipment Mfg., Ltd.. Device class: 2.
Clearance details
- Applicant
- Modern Medical Equipment Mfg., Ltd.
- Product code
- Code FAS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kwai Chung, Hong Kong, CN
Recent devices under product code FAS
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- K210651 — Resection Electrodes with HF cable
More clearances from Modern Medical Equipment Mfg., Ltd.
view allAdverse events under product code FAS
product code FAS- Death
- 3
- Injury
- 344
- Malfunction
- 1,130
- Total
- 1,477
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.