Cleared Traditional

SHANGRING

K121789 · Wuhu Snna Medical Treatment Appliance Technology C · Obstetrics & Gynecology
Aug 2012
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K121789 is an FDA 510(k) clearance for the SHANGRING, a Clamp, Circumcision (Class II — Special Controls, product code HFX), submitted by Wuhu Snna Medical Treatment Appliance Technology C (North Attleboro, US). The FDA issued a Cleared decision on August 3, 2012, 45 days after receiving the submission on June 19, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K121789 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2012
Decision Date August 03, 2012
Days to Decision 45 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

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