Cleared Traditional

VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150

K980350 · Cuda Products Co. · General & Plastic Surgery

Apr 1998

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K980350 is an FDA 510(k) clearance for the VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on April 28, 1998, 90 days after receiving the submission on January 28, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K980350 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 1998
Decision Date	April 28, 1998
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	GCJ — Laparoscope, General & Plastic Surgery
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
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).