Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm +6 more— 510(k) K183594

Clearance details

Device name as filed

Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J

Applicant

New Deantronics Taiwan , Ltd.

Product code

Code GEI

Device class

Class 2

Regulation

21 CFR 878.4400

Advisory panel

General, Plastic Surgery

Date received

2018-12-21

Decision date

2019-02-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

New Taipei City, TW

• 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

• K251492 — Irrigation Tubing Bipolar Cord Set2026-06-29
• K251899 — E Blator2025-10-01
• K202962 — Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft2020-11-20
• K201221 — Electrosurgical Generator2020-09-28
• K200455 — Trigger Switch and Cord2020-03-31

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 →