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
- Product 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 allMore 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.