Last synced on 2 December 2022 at 11:04 pm

Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190659
510(k) Type
Traditional
Applicant
Allwin Medical Devices, Inc.
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
12/2/2019
Days to Decision
263 days
Submission Type
Statement

Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190659
510(k) Type
Traditional
Applicant
Allwin Medical Devices, Inc.
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
12/2/2019
Days to Decision
263 days
Submission Type
Statement