VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR— 510(k) K112349

Clearance details

Applicant

Covidien, Formerly US Surgical A Divison of Tyco H

Product code

Product code GCJ

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2011-08-16

Decision date

2011-09-01

Decision

Substantially Equivalent

Clearance type

Special

Location

North Haven, CT, US

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• K131705 — ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY2013-07-01
• K130532 — IDRIVE ULTRA STERILIZATION TRAY2013-05-30
• K130717 — ENDO GIA RELOAD2013-04-18
• K130435 — VERSAPORT V2 BLADELESS OPTICAL TROCAR2013-03-14
• K122781 — RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD2013-02-05

Death

39

Injury

1,638

Malfunction

28,216

Other

11

Total

29,904

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 →

• Z-1467-2013 — Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.Class II·Terminated·Covidien LP·20130506
• Z-1468-2013 — Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.Class II·Terminated·Covidien LP·20130506
• Z-1469-2013 — Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.Class II·Terminated·Covidien LP·20130506
• Z-1470-2013 — Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.Class II·Terminated·Covidien LP·20130506
• Z-1471-2013 — Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.Class II·Terminated·Covidien LP·20130506
• Z-1472-2013 — Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.Class II·Terminated·Covidien LP·20130506

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112349.