Monopolar Cord
FDA 510(k) K193004 · New Deantronics Taiwan , Ltd.
510(k) numberK193004
Submission
- Device name
- Monopolar Cord
- Applicant
- New Deantronics Taiwan , Ltd.
New Taipei City, TW - Received
- October 28, 2019
- Decision date
- December 19, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K183126 | Electrosurgical accessoryGEI · Traditional | 05/08/2019SE |
| K183594 | Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic…GEI · Traditional | 02/19/2019SE |
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Questions and answers
When was Monopolar Cord cleared by the FDA?
Monopolar Cord (K193004) received a 510(k) decision of Substantially Equivalent on December 19, 2019, 52 days after the submission was received.
What is the product code of K193004?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.