510(k) K101428
K101428 is an FDA 510(k) premarket notification submitted by Ovesco Endoscopy AG for the device "OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET". The FDA issued a decision of Substantially Equivalent on Dec 1, 2010. The device falls under product code PKL (Hemostatic Metal Clip For The Gi Tract), a Class II device regulated under 21 CFR 876.4400. Ovesco Endoscopy AG has 15 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 1, 2010
- Date Received
- May 21, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Hemostatic Metal Clip For The Gi Tract
- Device Class
- Class II
- Regulation Number
- 876.4400
- Review Panel
- GU
- Submission Type
- 510(k)
Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.