Jimushi Sterile Urethral Catheter for single use— 510(k) K200134
Substantially EquivalentHangzhou Jimushi Meditech Co., Ltd.
FDA 510(k) clearance K200134 for Jimushi Sterile Urethral Catheter for single use, Substantially Equivalent on 2020-06-01. Applicant: Hangzhou Jimushi Meditech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hangzhou Jimushi Meditech Co., Ltd.
- Product code
- Code GBM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
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More clearances from Hangzhou Jimushi Meditech Co., Ltd.
view allAdverse events under product code GBM
product code GBM- Injury
- 397
- Malfunction
- 1,404
- Total
- 1,801
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.