510(k) K150852

SIC 8000 by Cosmo Technologies, Ltd. — Product Code PLL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 3, 2015
Date Received: March 31, 2015
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.

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)
K180068 — ORISE Gel (September 28, 2018)