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510(k) K091490

FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES by Thd Spa — Product Code FER

K091490 is an FDA 510(k) premarket notification submitted by Thd Spa for the device "FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES". The FDA issued a decision of Substantially Equivalent on June 11, 2009. The device falls under product code FER (Anoscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Thd Spa has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2009
Date Received
May 20, 2009
Clearance Type
Special
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 Thd Spa

  • K211623 — THD Procto Software System (June 24, 2021)
  • K193512 — THD Procto Software System (January 26, 2020)
  • K180135 — THD Anopress with THD SensyProbe (March 8, 2018)
  • K161785 — THD ANOPRESS (March 14, 2017)
  • K141657 — THD REVOLUTION (February 24, 2015)
  • K133687 — THD N-ANO ANOSCOPE (December 11, 2013)
  • K121135 — THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE (June 1, 2012)
  • K103647 — THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES (March 1, 2011)
  • K093497 — THD BANDY (July 15, 2010)
  • K090009 — THD SLIDE ONE (January 28, 2009)

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