510(k) K260997
K260997 is an FDA 510(k) premarket notification submitted by Endoclot Plus Co., Ltd. for the device "SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)". The FDA issued a decision of Substantially Equivalent on September 9, 2026. The device falls under product code PLL (Submucosal Injection Agent), a Class II device regulated under 21 CFR 876.1500. Endoclot Plus Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2026
- Date Received
- March 26, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Submucosal Injection Agent
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.