FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
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
K Number: K202962
·
Decision Nov 20, 2020
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
18
Review Days
51
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Basic Information
- Device Name
- 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
- K Number
- K202962
- 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
- September 30, 2020
- Decision Date
- November 20, 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 |
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Other Clearances by New Deantronics Taiwan , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251899 | E Blator | Oct 1, 2025 | Substantially Equivalent |
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| 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 |