510(k) K180068
K180068 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "ORISE Gel". The FDA issued a decision of Substantially Equivalent on September 28, 2018. The device falls under product code PLL (Submucosal Injection Agent), a Class II device regulated under 21 CFR 876.1500. Boston Scientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2018
- Date Received
- January 9, 2018
- 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.