Cleared Traditional

LASER LAPAROSCOPY SET

K873598 · Cuda Products Co. · Obstetrics & Gynecology
Jan 1988
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K873598 is an FDA 510(k) clearance for the LASER LAPAROSCOPY SET, 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 January 20, 1988, 138 days after receiving the submission on September 4, 1987. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K873598 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1987
Decision Date January 20, 1988
Days to Decision 138 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

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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