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510(k) K063587

XODUS MEDICAL ANTI-FOG SOLUTION by Xodus Medical, Inc. — Product Code OCT

K063587 is an FDA 510(k) premarket notification submitted by Xodus Medical, Inc. for the device "XODUS MEDICAL ANTI-FOG SOLUTION". The FDA issued a decision of Substantially Equivalent on January 9, 2007. The device falls under product code OCT (Anti Fog Solution And Accessories, Endoscopy), a Class II device regulated under 21 CFR 876.1500. Xodus Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2007
Date Received
December 1, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti Fog Solution And Accessories, Endoscopy
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

Other clearances by Xodus Medical, Inc.

  • K260903 — Hot Pink Pad Warming System (April 16, 2026)
  • K182080 — Scope Antifogging System (September 19, 2018)
  • K081647 — ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS (August 12, 2008)
  • K053433 — CAUTERY TIP CLEANER, MODEL 30500 (January 19, 2006)
  • K053321 — LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER (January 19, 2006)

Other clearances for product code OCT

  • K251068 — KnoxFog Anti-fogging Device (August 27, 2025)
  • K231822 — GOLFF Sterile Anti-Fog Solution (February 26, 2024)
  • K221293 — E-Brik Visualization Assistant (July 7, 2022)
  • K190864 — Konix Anti-Fog Solution (August 27, 2020)
  • K181887 — AMD Anti-Fog Solution (January 22, 2019)
  • K163257 — VitreOx Anti-fog Solution (May 24, 2017)
  • K152948 — Medline Anti-Fog Solution (February 4, 2016)
  • K120821 — LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM (May 11, 2012)
  • K111622 — UNIMAX ANTI-FOG SOLUTION (September 9, 2011)
  • K102452 — DEFOGGING AND CLEANING SOLUTION- FLO-X (December 23, 2010)

FDA data resources