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510(k) K150852

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

K150852 is an FDA 510(k) premarket notification submitted by Cosmo Technologies, Ltd. for the device "SIC 8000". The FDA issued a decision of Substantially Equivalent on September 3, 2015. The device falls under product code PLL (Submucosal Injection Agent), a Class II device regulated under 21 CFR 876.1500.

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

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  • 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)

FDA data resources