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510(k) Data Aggregation
K Number
K120814Device Name
PADLOCK CLIP-12
Manufacturer
Date Cleared
2012-09-06
(171 days)
Product Code
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
APONOS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Aponos Medical Padlock Clip™ is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of gastrointestinal organs.
The Padlock Clip is indicated for clip placement within the Gastro-intestinal (GI) tract for the purpose of:
- Endoscopic marking of lesions. .
- Hemostasis for .
- Mucosal/Sub mucosal defects o
- o Bleeding Ulcers
- Arteries <2mm o
- Polyps <1.5cm diameter O
- Diverticula in the Colon o
- Closure of GI tract luminal perforations < 20mm that can be treated . conservatively.
Device Description
The Padlock Clip™ ligation clip consists of a preloaded, radiopaque, single use, coin sized ligation clip made of superelastic shape memory alloy (Nitinol®) for tissue approximation device with opening sizes of 6 to 24mm on a flexible delivery system.
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