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510(k) K242668

Gastro Concepts Air Assist by Gastro Concepts, LLC — Product Code FER

K242668 is an FDA 510(k) premarket notification submitted by Gastro Concepts, LLC for the device "Gastro Concepts Air Assist". The FDA issued a decision of Substantially Equivalent on December 13, 2024. The device falls under product code FER (Anoscope And Accessories), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2024
Date Received
September 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anoscope And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine and perform procedures within the anus and rectum.

Other clearances for product code FER

  • K250645 — SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2 (October 9, 2025)
  • K230439 — WellCare Anoscope (December 22, 2023)
  • K200021 — Applied Medical Anoscope (January 6, 2021)
  • K171701 — GelPOINT Path Transanal Access Platform (July 20, 2017)
  • K133393 — GELPOINT PATH TRANSANAL ACCESS PLATFORM (January 2, 2014)
  • K133687 — THD N-ANO ANOSCOPE (December 11, 2013)
  • K121604 — ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT (July 27, 2012)
  • K121135 — THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE (June 1, 2012)
  • K110792 — GELPOINT PATH (May 23, 2011)
  • K103647 — THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES (March 1, 2011)

FDA data resources