Who is the manufacturer of MEDNEXT SURGICAL BUR?

Mednext, Inc. submitted the Traditional clearance for MEDNEXT SURGICAL BUR (K970023).

What is the FDA product code for MEDNEXT SURGICAL BUR?

HWE. It is classified under 21 CFR 878.4820 as a Class 1 device in the General, Plastic Surgery panel.

What is the regulatory pathway for MEDNEXT SURGICAL BUR?

510(k) clearance (submission type: Traditional).

MEDNEXT SURGICAL BUR

K970023 · Mednext, Inc. · HWE · Feb 28, 1997 · General, Plastic Surgery

Device Facts

Record ID	K970023
Device Name	MEDNEXT SURGICAL BUR
Applicant	Mednext, Inc.
Product Code	HWE · General, Plastic Surgery
Decision Date	Feb 28, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4820
Device Class	Class 1

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.