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510(k) K220434

Blue Eye (TS-905) by The Standard Co., Ltd. — Product Code PLL

K220434 is an FDA 510(k) premarket notification submitted by The Standard Co., Ltd. for the device "Blue Eye (TS-905)". The FDA issued a decision of Substantially Equivalent on August 12, 2022. The device falls under product code PLL (Submucosal Injection Agent), a Class II device regulated under 21 CFR 876.1500. The Standard Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2022
Date Received
February 15, 2022
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 by The Standard Co., Ltd.

  • K241591 — Blue Eye (July 3, 2024)

Other clearances for product code PLL

  • K241591 — Blue Eye (July 3, 2024)
  • 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)
  • K150852 — SIC 8000 (September 3, 2015)

FDA data resources