Cleared Traditional

K141515 - AED HYSTEROSCOPE AND ACCESSORIES
(FDA 510(k) Clearance)

K141515 · National Advanced Endoscopy Devices, Inc. · Obstetrics & Gynecology
Jan 2015
Decision
212d
Days
Class 2
Risk

K141515 is an FDA 510(k) clearance for the AED HYSTEROSCOPE AND ACCESSORIES. This device is classified as a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH).

Submitted by National Advanced Endoscopy Devices, Inc. (Canoga Park, US). The FDA issued a Cleared decision on January 7, 2015, 212 days after receiving the submission on June 9, 2014.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K141515 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2014
Decision Date January 07, 2015
Days to Decision 212 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIH — Hysteroscope (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1690

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