Cleared Special

K131373 - SHANGRING

K131373 is an FDA 510(k) clearance for SHANGRING, manufactured by Wuhu Snnda Medical Treatment Appliance Technology. The device is a Class 2 Obstetrics & Gynecology device with product code HFX cleared through the Special 510(k) pathway after a 43-day FDA review.

K131373 · Wuhu Snnda Medical Treatment Appliance Technology · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
43d
Days
Class 2
Risk

K131373 is an FDA 510(k) clearance for the SHANGRING. Classified as Clamp, Circumcision (product code HFX), Class II - Special Controls.

Submitted by Wuhu Snnda Medical Treatment Appliance Technology (Shanghai, CN). The FDA issued a Cleared decision on June 25, 2013 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K131373

510(k) Number K131373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 161d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

HFX Device Classification - Class 2, Special Controls

Product Code HFX Clamp, Circumcision
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HFX Clamp, Circumcision

All 26
Devices cleared under the same product code (HFX) and FDA review panel - the closest regulatory comparables to K131373.
Konig Mogen Clamp
K212911 · Medline Industries, Inc. · Nov 2022
Circumplast Circumcision Device
K151095 · Novadien Healthcare · Sep 2015
MALE CIRCUMCISION KITS:RAPIDECLAMP
K142163 · Medicfit Technology Sdn Bhd · Apr 2015
SHANGRING
K121789 · Wuhu Snna Medical Treatment Appliance Technology C · Aug 2012
PREPEX SYSTEM
K103695 · Circ Medtech · Jan 2012
MEDICON MOGEN CLAMP
K100916 · Medicon EG · Dec 2010
K131373 · SHANGRING
Download PDF Wuhu Snnda Medical Tr…