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510(k) K070913

SELF-LIGHT DISPOSABLE ANOSCOPE by Sapimed S.P.A. — Product Code FER

K070913 is an FDA 510(k) premarket notification submitted by Sapimed S.P.A. for the device "SELF-LIGHT DISPOSABLE ANOSCOPE". The FDA issued a decision of Substantially Equivalent on August 10, 2007. The device falls under product code FER (Anoscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Sapimed S.P.A. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2007
Date Received
April 2, 2007
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 by Sapimed S.P.A.

  • K070881 — LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 (September 26, 2007)
  • K070915 — SAPIMED DISPOSABLE SIGMOIDOSCOPE (July 6, 2007)

Other clearances for product code FER

  • K250645 — SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2 (October 9, 2025)
  • K242668 — Gastro Concepts Air Assist (December 13, 2024)
  • 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)

FDA data resources