510(k) K183309
K183309 is an FDA 510(k) premarket notification submitted by Ovesco Endoscopy AG for the device "stentfix OTSC System Set". The FDA issued a decision of Substantially Equivalent on October 22, 2019. 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 at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2019
- Date Received
- November 29, 2018
- 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
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.