Cleared Traditional

ULTRABLATOR ELECTRODE

K030720 · Linvatec Corp. · General & Plastic Surgery

Jun 2003

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K030720 is an FDA 510(k) clearance for the ULTRABLATOR ELECTRODE, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on June 3, 2003, 88 days after receiving the submission on March 7, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K030720 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 2003
Decision Date	June 03, 2003
Days to Decision	88 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

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).