Cleared Traditional

PANPAC DISPOSABLE VACUUM CURETTES

K161106 · Panpac Medical Corporation · Obstetrics & Gynecology
Jan 2017
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K161106 is an FDA 510(k) clearance for the PANPAC DISPOSABLE VACUUM CURETTES, a Cannula, Suction, Uterine (Class II — Special Controls, product code HGH), submitted by Panpac Medical Corporation (Shi-Chih Dist., TW). The FDA issued a Cleared decision on January 13, 2017, 269 days after receiving the submission on April 19, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5070.

Submission Details

510(k) Number K161106 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2016
Decision Date January 13, 2017
Days to Decision 269 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HGH — Cannula, Suction, Uterine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5070