Cleared Special

SHANGRING

K131373 · Wuhu Snnda Medical Treatment Appliance Technology · Obstetrics & Gynecology
Jun 2013
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K131373 is an FDA 510(k) clearance for the SHANGRING, a Clamp, Circumcision (Class II — Special Controls, product code HFX), submitted by Wuhu Snnda Medical Treatment Appliance Technology (Shanghai, CN). The FDA issued a Cleared decision on June 25, 2013, 43 days after receiving the submission on May 13, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K131373 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2013
Decision Date June 25, 2013
Days to Decision 43 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HFX — Clamp, Circumcision
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530