AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR— 510(k) K081169
Substantially EquivalentCovidien Lp, Formerly Registered AS United States
FDA 510(k) clearance K081169 for AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR, Substantially Equivalent on 2008-05-23. Applicant: Covidien Lp, Formerly Registered AS United States. Device class: 2.
Clearance details
- Applicant
- Covidien Lp, Formerly Registered AS United States
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- North Haven, CT, US
Recent devices under product code GCJ
view all- K262397 — CuratOR EX2742
- K260884 — UNIDRIVE Select System
- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from Covidien Lp, Formerly Registered AS United States
view all- K091869 — SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS
- K091900 — ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
- K083519 — AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS
- K090419 — SILS STITCH ENDOSCOPIC SUTURING DEVICE
- K082619 — SILS PORT, MODELS SILSPT5, SILSPT12
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.