CSS

FDA 510(k) K031564 · Medical Scientific, Inc.

Substantially Equivalent

510(k) numberK031564

Submission

Device name
CSS
Applicant
Medical Scientific, Inc.
Taunton, MA, US
Received
May 19, 2003
Decision date
October 7, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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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Questions and answers

When was CSS cleared by the FDA?

CSS (K031564) received a 510(k) decision of Substantially Equivalent on October 7, 2003, 141 days after the submission was received.

What is the product code of K031564?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.