OverStitch 2-0 Polypropylene Suture— 510(k) K191439

Name: FDA 510(k) clearance K191439
Creator: U.S. Food and Drug Administration
Published: 2019-08-29

Substantially Equivalent

Apollo Endosurgery

FDA 510(k) clearance K191439 for OverStitch 2-0 Polypropylene Suture, Substantially Equivalent on 2019-08-29. Applicant: Apollo Endosurgery. Device class: 2.

Clearance details

Applicant: Apollo Endosurgery
Product code: Code OCW
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-05-30
Decision date: 2019-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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K213271 — MedicloseTM System2023-08-31
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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.