Cleared Traditional

LIGHTSOURCE OR ILLUMINATOR

K980166 · Cuda Products Co. · Obstetrics & Gynecology
Apr 1998
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K980166 is an FDA 510(k) clearance for the LIGHTSOURCE OR ILLUMINATOR, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on April 1, 1998, 75 days after receiving the submission on January 16, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K980166 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 1998
Decision Date April 01, 1998
Days to Decision 75 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HET — Laparoscope, Gynecologic (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1720

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