ORISE Gel— 510(k) K180068

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K180068 for ORISE Gel, Substantially Equivalent on 2018-09-28. Applicant: Boston Scientific. Device class: 2.

Clearance details

Applicant: Boston Scientific
Product code: Code PLL
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2018-01-09
Decision date: 2018-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K180068

K-number listed on FDA's recall record

Z-0224-2023 — ORISE Gel Submucosal Lifting Agent--Indicated 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 other suitable endoscopic device Packaged as follows: UPN: (1)Twin Pack Box 1 M00519200 (2)Twin Pack Box 10 M00519201 (3)Single Pack Box 1 M00519220 (4)Single Pack Box 10 M00519221Class II·Ongoing·Boston Scientific Corporation·20221010

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180068.

Data sourced from openFDA. This site is unofficial and independent of the FDA.