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510(k) K200021

Applied Medical Anoscope by Applied Medical Resources — Product Code FER

K200021 is an FDA 510(k) premarket notification submitted by Applied Medical Resources for the device "Applied Medical Anoscope". The FDA issued a decision of Substantially Equivalent on January 6, 2021. The device falls under product code FER (Anoscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Applied Medical Resources has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2021
Date Received
January 6, 2020
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 Applied Medical Resources

  • K252740 — Voyant® Open Fusion Device (EB240/Open Fusion) (November 4, 2025)
  • K252442 — Kii Structural Balloon Access System (October 31, 2025)
  • K243152 — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (October 2, 2025)
  • K201212 — Voyant Open Fusion Device (June 5, 2020)
  • K200598 — Voyant Maryland Fusion Device (April 8, 2020)
  • K193292 — Voyant 5mm Fusion Device, Voyant Maryland Fusion Device (December 20, 2019)
  • K191294 — Transvaginal Access Platform (September 6, 2019)
  • K182653 — Voyant Maryland Fusion Device (November 14, 2018)
  • K182244 — Voyant Electrosurgical Generator (October 11, 2018)
  • K182024 — Dissecting Balloon System (August 30, 2018)

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)
  • 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