DeviceClearance

Product code OCW— Gastroenterology, Urology

ACE STAPLER AND CARTRIDGE

Classification name
Endoscopic Tissue Approximation Device
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
70
First cleared
Most recent

FDA classification definition

“To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.”

— U.S. Food and Drug Administration, device classification record for product code OCW under 21 CFR 876.1500, via openFDA

Market context for product code OCW

FDA has cleared 70 devices under product code OCW between 1994 and 2026, filed by 38 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OCW

Adverse events under product code OCW

product code OCW
Death
6
Injury
443
Malfunction
1,023
Other
2
Total
1,474

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OCW

Data sourced from openFDA. This site is unofficial and independent of the FDA.