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510(k) K905590

UCEZ - STERILE LENS FOG REDUCTION DEVICE by Inman Liebelt Corp. — Product Code OCT

K905590 is an FDA 510(k) premarket notification submitted by Inman Liebelt Corp. for the device "UCEZ - STERILE LENS FOG REDUCTION DEVICE". The FDA issued a decision of Substantially Equivalent on May 10, 1991. The device falls under product code OCT (Anti Fog Solution And Accessories, Endoscopy), a Class II device regulated under 21 CFR 876.1500. Inman Liebelt Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1991
Date Received
December 13, 1990
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 Inman Liebelt Corp.

  • K912211 — INTRAVASCULAR CATHETER SECURMENT DEVICE (August 9, 1991)
  • K912146 — URETERAL CATHETER HOLDER (July 26, 1991)
  • K905583 — ILC FORCEPS PADS (April 12, 1991)
  • K903611 — ILC LEG BAG HOLDER (October 26, 1990)
  • K903610 — O.R. TIP CLEANER (October 19, 1990)

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