510(k) K180068

ORISE Gel by Boston Scientific — Product Code PLL

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.

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K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX (August 30, 2024)
K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (April 29, 2024)
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K232633 — Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Elec (November 28, 2023)

Other clearances for product code PLL

K241591 — Blue Eye (July 3, 2024)
K220434 — Blue Eye (TS-905) (August 12, 2022)
K221385 — LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) (August 11, 2022)
K200071 — Blue Beacon Submucosal Injectable Solution (November 3, 2020)
K202376 — EverLift Submucosal Lifting Agent (September 30, 2020)
K191923 — EverLift Submucosal Lifting Agent (June 20, 2020)
K191254 — EndoClot (January 30, 2020)
K150852 — SIC 8000 (September 3, 2015)