ProCinch Adjustable Loop Device— 510(k) K150416

Substantially Equivalent

Stryker Endoscopy

FDA 510(k) clearance K150416 for ProCinch Adjustable Loop Device, Substantially Equivalent on 2015-04-17. Applicant: Stryker Endoscopy.

Clearance details

Applicant: Stryker Endoscopy
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2015-02-18
Decision date: 2015-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.