SILS STITCH ENDOSCOPIC SUTURING DEVICE— 510(k) K090419

Name: FDA 510(k) clearance K090419
Creator: U.S. Food and Drug Administration
Published: 2009-03-09

Substantially Equivalent

Covidien Lp, Formerly Registered AS United States

FDA 510(k) clearance K090419 for SILS STITCH ENDOSCOPIC SUTURING DEVICE, Substantially Equivalent on 2009-03-09. Applicant: Covidien Lp, Formerly Registered AS United States. Device class: 2.

Clearance details

Applicant: Covidien Lp, Formerly Registered AS United States
Product code: Code OCW
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2009-02-18
Decision date: 2009-03-09
Decision: Substantially Equivalent
Clearance type: Special
Location: North Haven, CT, US

Download summary PDF View on FDA.gov ↗

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More clearances from Covidien Lp, Formerly Registered AS United States

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K091869 — SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS2009-09-01
K091900 — ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE2009-07-16
K083519 — AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS2009-04-10
K082619 — SILS PORT, MODELS SILSPT5, SILSPT122008-11-07
K082659 — MODIFIED ENDO STICH2008-09-19

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.