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Submucosal Injection Agent

FDA product code PLL · 9 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.1500
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-09-28 – 2026-09-09

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.

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