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510(k) K241591

Blue Eye by The Standard Co., Ltd. — Product Code PLL

K241591 is an FDA 510(k) premarket notification submitted by The Standard Co., Ltd. for the device "Blue Eye". The FDA issued a decision of Substantially Equivalent on July 3, 2024. 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
July 3, 2024
Date Received
June 3, 2024
Clearance Type
Special
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.

  • K220434 — Blue Eye (TS-905) (August 12, 2022)

Other clearances for product code PLL

  • 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)
  • K150852 — SIC 8000 (September 3, 2015)

FDA data resources