WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT— 510(k) K121380
Substantially EquivalentTeleflexmedical, Inc.
FDA 510(k) clearance K121380 for WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT, Substantially Equivalent on 2012-05-25. Applicant: Teleflexmedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Teleflexmedical, Inc.
- 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
- Durham, NC, US
Recent devices under product code GCJ
view allMore clearances from Teleflexmedical, Inc.
view allAdverse 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 →
Recalls naming K121380
K-number listed on FDA's recall record- Z-1278-2014 — 5/10 mm Weck¿, Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
- Z-1283-2014 — 5/10/12 mm Weck¿ Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
- Z-1325-2014 — 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405912R. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121380.
Data sourced from openFDA. This site is unofficial and independent of the FDA.