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510(k) K191254

EndoClot by Endoclot Plus Co., Ltd. — Product Code PLL

K191254 is an FDA 510(k) premarket notification submitted by Endoclot Plus Co., Ltd. for the device "EndoClot". The FDA issued a decision of Substantially Equivalent on January 30, 2020. The device falls under product code PLL (Submucosal Injection Agent), a Class II device regulated under 21 CFR 876.1500. Endoclot Plus Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2020
Date Received
May 10, 2019
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 Endoclot Plus Co., Ltd.

  • K190677 — EndoClot (January 29, 2021)
  • K162197 — EndoClot (January 18, 2017)

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)
  • K180068 — ORISE Gel (September 28, 2018)
  • K150852 — SIC 8000 (September 3, 2015)

FDA data resources