MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
FDA 510(k) K172775 · Teleflexmedical, Inc.
510(k) numberK172775
Submission
- Device name
- MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
- Applicant
- Teleflexmedical, Inc.
Morrisville, NC, US - Received
- September 14, 2017
- Decision date
- February 12, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCW – Endoscopic Tissue Approximation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
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Questions and answers
When was MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle cleared by the FDA?
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle (K172775) received a 510(k) decision of Substantially Equivalent on February 12, 2018, 151 days after the submission was received.
What is the product code of K172775?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.