510(k) K213338
K213338 is an FDA 510(k) premarket notification submitted by Incore Co., Ltd. for the device "CORE-CLIP". The FDA issued a decision of Substantially Equivalent on June 23, 2022. The device falls under product code PKL (Hemostatic Metal Clip For The Gi Tract), a Class II device regulated under 21 CFR 876.4400. Incore Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2022
- Date Received
- October 7, 2021
- 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.