Capio SLIM Suture Capturing Device
FDA 510(k) K172060 · Boston Scientific Corporation
510(k) numberK172060
Submission
- Device name
- Capio SLIM Suture Capturing Device
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- July 7, 2017
- Decision date
- November 3, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PWI – Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4910
- Specialty
- Obstetrics/Gynecology
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair
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Questions and answers
When was Capio SLIM Suture Capturing Device cleared by the FDA?
Capio SLIM Suture Capturing Device (K172060) received a 510(k) decision of Substantially Equivalent on November 3, 2017, 119 days after the submission was received.
What is the product code of K172060?
The FDA product code is PWI – Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse, a Class II (moderate risk) device regulated under 21 CFR 884.4910.