Cleared Traditional

BIPOLATOR 50

K874779 · Treace Medical, Inc. · General & Plastic Surgery

Jan 1988

Decision

71d

Days

Class 2

Risk

About This 510(k) Submission

K874779 is an FDA 510(k) clearance for the BIPOLATOR 50, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on January 29, 1988, 71 days after receiving the submission on November 19, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K874779 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 1987
Decision Date	January 29, 1988
Days to Decision	71 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

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).