510(k) K183590
K183590 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip". The FDA issued a decision of Substantially Equivalent on Aug 1, 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. Olympus Medical Systems Corp. has 103 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 1, 2019
- Date Received
- Dec 21, 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
- 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.