Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm— 510(k) K150253
Substantially EquivalentTaiwan Surgical Corporation
FDA 510(k) clearance K150253 for Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm, Substantially Equivalent on 2015-04-01. Applicant: Taiwan Surgical Corporation. Device class: 2.
Clearance details
- Applicant
- Taiwan Surgical Corporation
- 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
- Zhubei City, TW
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More clearances from Taiwan Surgical Corporation
view allAdverse 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.