G-PROX ENDOSCOPIC GRASPER— 510(k) K061276

Name: FDA 510(k) clearance K061276
Creator: U.S. Food and Drug Administration
Published: 2006-12-06

Substantially Equivalent

Usgi Medical

FDA 510(k) clearance K061276 for G-PROX ENDOSCOPIC GRASPER, Substantially Equivalent on 2006-12-06. Applicant: Usgi Medical. Device class: 2.

Clearance details

Applicant: Usgi Medical
Product code: Code GAT
Device class: Class 2
Regulation: 21 CFR 878.5000
Advisory panel: General, Plastic Surgery
Date received: 2006-05-08
Decision date: 2006-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAT

view all

K253910 — Stitch - Suture Wires and Tapes2026-08-22
K261021 — EasyWhip Family2026-07-01
K260775 — Polyethylene; Polyethylene Fusion; Polyethylene OrthoTape2026-05-06
K254275 — HyperSuture All Green Extension Line2026-03-23
K254188 — Meniscus Versaflex2026-02-19

More clearances from Usgi Medical

view all

K103688 — G-PROX EZ ENDOSCOPIC GRASPER2011-01-14
K102931 — G-CINCH SUTURE GRASPER2010-12-30
K102916 — G-CATH TISSUE ANCHOR DELIVERY CATHETER2010-10-20
K100251 — G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 2053332010-02-17
K093018 — G-PROX ENDOSCOPIC GRASPER, MODEL 2053332009-10-07

Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.