PLLClass II

Submucosal Injection Agent

Gastroenterology, Urology · 21 CFR 876.1500

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.

MDR events70All time

Recalls1All time

Registered firms16Currently listed

510(k) clearances9All time

Recent MDR events

70 adverse event reports on file

See all →

Event type breakdown

Injury56

Malfunction14

Most-reported manufacturers

See all →

Boston Scientific Corporation64 Cosmo Technologies, Ltd.2 Unspecified1 Endoclot Plus Co., Ltd.1 Unk1 Us Endoscopy1

Recalls

1 recall events for this product code

See all →

Boston Scientific Corporation
Open, ClassifiedNov 11, 2022
ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or
***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention
Z-0224-2023 · View FDA record ↗

Registered firms

16 firms currently registered for this product code

See all →

510(k) clearances

9 clearances for this product code

See all →