Bistat 70/70-I Electrosurgical Unit

Q: What is the product code of K933131?

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

FDA 510(k) K933131 · Medical and Scientific Enterprises, Inc.

Substantially Equivalent

510(k) numberK933131

Submission

Device name: Bistat 70/70-I Electrosurgical Unit
Applicant: Medical and Scientific Enterprises, Inc.
North Attleboro, MA, US
Received: June 28, 1993
Decision date: February 15, 1994
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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K913881	Endostat Electrosurgical UnitKNS · Traditional	11/01/1991SE
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K882453	Polyscan Digital ScannerIYW · Traditional	11/23/1988SE
K861233	Dual Photon Bone DensitometerKGI · Traditional	03/03/1987SE

Questions and answers

When was Bistat 70/70-I Electrosurgical Unit cleared by the FDA?

Bistat 70/70-I Electrosurgical Unit (K933131) received a 510(k) decision of Substantially Equivalent on February 15, 1994, 232 days after the submission was received.

What is the product code of K933131?

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