Cleared Traditional

MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST

K962273 · Marlo Surgical Technology · Obstetrics & Gynecology
Jul 1996
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K962273 is an FDA 510(k) clearance for the MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST, a Cannula, Intrauterine Insemination (Class II — Special Controls, product code MFD), submitted by Marlo Surgical Technology (Willoughby, US). The FDA issued a Cleared decision on July 31, 1996, 48 days after receiving the submission on June 13, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number K962273 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 1996
Decision Date July 31, 1996
Days to Decision 48 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MFD — Cannula, Intrauterine Insemination
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5250

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