Qa-Es

FDA 510(k) K971092 · Smith

Substantially Equivalent

510(k) numberK971092

Submission

Device name
Qa-Es
Applicant
Smith
Crofton, MD, US
Received
March 26, 1997
Decision date
April 23, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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K261179AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional Gimmi GmbH07/22/2026SE
K253504Volnewmer™GEI · Traditional Classys, Inc.07/13/2026SE
K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional Olympus Medical Systems Corp.07/01/2026SE
K253484Lutronic GeniusGEI · Traditional Cynosure Lutronic Technology Corporation06/29/2026SE
K251492Irrigation Tubing Bipolar Cord SetGEI · Traditional New Deantronics Taiwan , Ltd.06/29/2026SE
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Questions and answers

When was Qa-Es cleared by the FDA?

Qa-Es (K971092) received a 510(k) decision of Substantially Equivalent on April 23, 1997, 28 days after the submission was received.

What is the product code of K971092?

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