INNOVASIVE DEVICES Y-KNOT SUTURE CLIP— 510(k) K973313

Substantially Equivalent

Innovasive Devices, Inc.

FDA 510(k) clearance K973313 for INNOVASIVE DEVICES Y-KNOT SUTURE CLIP, Substantially Equivalent on 1997-12-01. Applicant: Innovasive Devices, Inc..

Clearance details

Applicant: Innovasive Devices, Inc.
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 1997-09-03
Decision date: 1997-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

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, 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.