Cleared Traditional

FLOWGUN ELECTROCAUTERY PROBE HANDLE

K935970 · O.R. Concepts, Inc. · General & Plastic Surgery

May 1994

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K935970 is an FDA 510(k) clearance for the FLOWGUN ELECTROCAUTERY PROBE HANDLE, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by O.R. Concepts, Inc. (Burnsville, US). The FDA issued a Cleared decision on May 16, 1994, 154 days after receiving the submission on December 13, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K935970 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 1993
Decision Date	May 16, 1994
Days to Decision	154 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	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).