FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Electrosurgical Generator
K Number: K201221
·
Decision Sep 28, 2020
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
18
Review Days
145
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Electrosurgical Generator
- K Number
- K201221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- New Deantronics Taiwan , Ltd.
- Date Received
- May 6, 2020
- Decision Date
- September 28, 2020
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolSeal Generator® (CSL-200-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROMARK System (NMK00301)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAP-iX2N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MILAN System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by New Deantronics Taiwan , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251899 | E Blator | Oct 1, 2025 | Substantially Equivalent |
| 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 | Substantially Equivalent |
| K200455 | Trigger Switch and Cord | Mar 31, 2020 | Substantially Equivalent |
| K193004 | Monopolar Cord | Dec 19, 2019 | Substantially Equivalent |
| K191064 | Argon Handset | Jun 12, 2019 | Substantially Equivalent |
| K183126 | Electrosurgical accessory | May 8, 2019 | Substantially Equivalent |
| K183594 | 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 | Feb 19, 2019 | Substantially Equivalent |
| K180908 | Irrigation Tubing Bipolar Cord Set | May 18, 2018 | Substantially Equivalent |
| K170161 | New Deantronics E Green Electrosurgical Monopolar Pencils | Mar 29, 2017 | Substantially Equivalent |
| K153265 | New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated | Jan 5, 2016 | Substantially Equivalent |