ORISE Gel Submucosal Injection Agent
510(k) K180068
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180068 | Date28 Sep 2018 | StatusActive |
Recalls
-
- Ongoing Z-0224-2023
***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
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- ORISE Gel
- 510(k) Number
- FDA Product Code
- PLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The ORISE Gel Submucosal Injection Agent is a Submucosal Injection Agent (per FDA classification PLL) designed to lift submucosal tissue during endoscopic procedures. It is intended for use in raising lesions, such as polyps, adenomas, or early-stage cancers, within the gastrointestinal mucosa to facilitate resection via endoscopic snare or other devices.
Supplied as a sterile, single-use syringe-based formulation, this device is regulated under FDA 510(k) clearance (K180068) and classified as a Class II medical device. It is used exclusively in controlled endoscopic settings and must be handled in accordance with sterile technique. No active regulatory status beyond the noted clearance is implied.
Other devices from Boston Scientific
Questions
AI-generated answers, 19 Sep 2026
What types of lesions or tissues can the ORISE Gel be used to lift during endoscopic procedures?
The ORISE Gel is specifically designed to lift submucosal tissue during endoscopic procedures, such as polyps, adenomas, or early-stage cancers within the gastrointestinal mucosa. Its purpose is to elevate these lesions to facilitate safer resection using endoscopic snare or similar devices.
How is the ORISE Gel supplied, and is it reusable?
The ORISE Gel comes as a sterile, single-use syringe-based formulation. This design ensures sterility and prevents cross-contamination between patients, making it unsuitable for reuse.
What medical specialties are primarily authorized to use the ORISE Gel?
The ORISE Gel is authorized for use in the specialties of Gastroenterology and Urology, as indicated by its regulatory classification and advisory committee review. It is intended exclusively for controlled endoscopic settings.
Does the ORISE Gel require any special handling or storage conditions?
Since the ORISE Gel is supplied as a sterile, single-use syringe, it must be handled in accordance with sterile technique to maintain its integrity. While specific storage conditions aren’t detailed in the data, standard sterile medical device storage practices (e.g., refrigeration if required, protection from light) should be followed to preserve its efficacy.
What regulatory pathway was followed for the ORISE Gel’s approval, and what class is it assigned?
The ORISE Gel underwent a Traditional 510(k) review and was determined to be Substantially Equivalent to a predicate device. It is classified as a Class II medical device under FDA regulations, indicating moderate risk and requiring compliance with specific controls.