# New Deantronics Taiwan, Ltd.

- Location (FDA's records): New Taipei City, TW
- FDA decisions: 19 (1998–2026): 19 510(k) clearances
- Product codes: GEI (19)
- 510(k) review time since 2016: median 57 days, against 99 for FDA's reviews in the same codes and years (9 of 12 faster)
- Predicates its devices cite: 14 (3 its own); citations of its devices by later devices: 7 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Valleylab, Inc.: 5 (https://510kreport.com/company/valleylab)
- Covidien: 2 (https://510kreport.com/company/covidien)
- E Surgical, LLC: 1 (https://510kreport.com/company/e-surgical)
- Medos International SARL: 1 (https://510kreport.com/company/medos-international)
- Megadyne Medical Products, Inc.: 1 (https://510kreport.com/company/megadyne-medical-products)
- Modern Medical Equipment Manufacturing Limited: 1 (https://510kreport.com/company/modern-medical-equipment-manufacturing)

## Firms that cite its devices most
- E Surgical, LLC: 1 (https://510kreport.com/company/e-surgical)
- Alesi Surgical, Ltd.: 1 (https://510kreport.com/company/alesi-surgical)
- Us Endoscopy: 1 (https://510kreport.com/company/us-endoscopy)
- Valley Forge Scientific Corp.: 1 (https://510kreport.com/company/valley-forge-scientific)

## Its most-cited devices
- K153265: New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated (2016), cited by 2
- K982742: Disposable Hand Switching Pencil, Rocker Switch, One Piece and One Piece Holster Models SB 313 RS, SB 313 RSH (1998), cited by 2
- K982748: BI-Polar Cord Set 1.88 TR, BI-Polar Cord Set 1.83 TR, Model #'S SB223, SB 224 (1998), cited by 1
- K982744: Disposable Hand Switching Pencil, Push Button, 2 Piece with and Without Holster, Models SB 312PB, SB 312 PBH (1998), cited by 1
- K982749: Monopolar Foot Control Pencil, Model # SB 112-2 (1998), cited by 1

## Recent decisions
- K251492: Irrigation Tubing Bipolar Cord Set (Jun 29, 2026)
- K251899: E Blator (Oct 1, 2025)
- 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, 15ft (Nov 20, 2020)
- K201221: Electrosurgical Generator (Sep 28, 2020)
- K200455: Trigger Switch and Cord (Mar 31, 2020)
- K193004: Monopolar Cord (Dec 19, 2019)
- K191064: Argon Handset (Jun 12, 2019)
- K183126: Electrosurgical accessory (May 8, 2019)

Source page: https://510kreport.com/company/new-deantronics-taiwan