Cleared Traditional

ELECTROSURGICAL CAUTERY PROBES

K981188 · Microline Pentax, Inc. · General & Plastic Surgery

May 1998

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K981188 is an FDA 510(k) clearance for the ELECTROSURGICAL CAUTERY PROBES, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Microline Pentax, Inc. (Wellesley, US). The FDA issued a Cleared decision on May 20, 1998, 48 days after receiving the submission on April 2, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K981188 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 02, 1998
Decision Date	May 20, 1998
Days to Decision	48 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).