ProCinch Adjustable Loop Device
FDA 510(k) K150416 · Stryker Endoscopy
510(k) numberK150416
Submission
- Device name
- ProCinch Adjustable Loop Device
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- February 18, 2015
- Decision date
- April 17, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was ProCinch Adjustable Loop Device cleared by the FDA?
ProCinch Adjustable Loop Device (K150416) received a 510(k) decision of Substantially Equivalent on April 17, 2015, 58 days after the submission was received.
What is the product code of K150416?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.