Cleared Traditional

SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE

K862861 · Directed Energy, Inc. · Obstetrics & Gynecology
Oct 1986
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K862861 is an FDA 510(k) clearance for the SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE, a Laser, Surgical, Gynecologic (Class II — Special Controls, product code HHR), submitted by Directed Energy, Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 27, 1986, 90 days after receiving the submission on July 29, 1986. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4550.

Submission Details

510(k) Number K862861 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1986
Decision Date October 27, 1986
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HHR — Laser, Surgical, Gynecologic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4550

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