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510(k) K942576

CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE by White Knight Healthcare — Product Code OCT

K942576 is an FDA 510(k) premarket notification submitted by White Knight Healthcare for the device "CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE". The FDA issued a decision of Substantially Equivalent on July 5, 1994. The device falls under product code OCT (Anti Fog Solution And Accessories, Endoscopy), a Class II device regulated under 21 CFR 876.1500. White Knight Healthcare has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1994
Date Received
May 31, 1994
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 White Knight Healthcare

  • K001892 — WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) (April 3, 2001)
  • K001893 — WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) (April 2, 2001)
  • K001997 — WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) (April 2, 2001)
  • K951984 — WHITE KNIGHT SURGEON'S VEST (July 25, 1995)
  • K943809 — MONOGARD FACE SHIELD (November 28, 1994)
  • K942577 — SURGICAL TIP CLEANER (July 26, 1994)
  • K934969 — DUALGARD FACE SHIELD (March 28, 1994)

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