DAN MONOPOLAR LAP ACCESSORIES— 510(k) K052759

Name: FDA 510(k) clearance K052759
Creator: U.S. Food and Drug Administration
Published: 2006-06-14

Substantially Equivalent

Dannoritzer Medizintechnik GmbH & Co. KG

FDA 510(k) clearance K052759 for DAN MONOPOLAR LAP ACCESSORIES, Substantially Equivalent on 2006-06-14. Applicant: Dannoritzer Medizintechnik GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Dannoritzer Medizintechnik GmbH & Co. KG
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2005-09-30
Decision date: 2006-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEI

view all

K254185 — Potenza Prime2026-09-11
K262364 — Ellian Enigma RF Device2026-09-02
K253859 — Scarlet Pro (Scarlet Pro)2026-08-27
K252535 — Inno-Switch Laparoscopic Instruments2026-08-25
K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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 →

Recalls naming K052759

K-number listed on FDA's recall record

Z-0062-2019 — Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulationClass III·Terminated·Dannoritzer Medizintechnik GmbH & Co. KG·20180806

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052759.

Data sourced from openFDA. This site is unofficial and independent of the FDA.