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510(k) K011825

RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE by Sightline Technologies , Ltd. — Product Code FER

K011825 is an FDA 510(k) premarket notification submitted by Sightline Technologies , Ltd. for the device "RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE". The FDA issued a decision of Substantially Equivalent on July 11, 2001. The device falls under product code FER (Anoscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Sightline Technologies , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2001
Date Received
June 11, 2001
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 Sightline Technologies , Ltd.

  • K032688 — COLONOSIGHT MODEL 510B (March 5, 2004)
  • K994130 — RECTOSIGHT RS 300-04 (June 30, 2000)

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