Cleared Traditional

LIGASURE VESSEL SEALING SYSTEM

K981916 · Valleylab, Inc. · General & Plastic Surgery

Aug 1998

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K981916 is an FDA 510(k) clearance for the LIGASURE VESSEL SEALING SYSTEM, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on August 28, 1998, 88 days after receiving the submission on June 1, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K981916 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 1998
Decision Date	August 28, 1998
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).