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510(k) K932449

DR. FOG by O.R. Concepts, Inc. — Product Code OCT

K932449 is an FDA 510(k) premarket notification submitted by O.R. Concepts, Inc. for the device "DR. FOG". The FDA issued a decision of Substantially Equivalent on August 11, 1993. The device falls under product code OCT (Anti Fog Solution And Accessories, Endoscopy), a Class II device regulated under 21 CFR 876.1500. O.R. Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1993
Date Received
May 20, 1993
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 O.R. Concepts, Inc.

  • K941337 — FLOWGUN ELECTROCAUTERY PROBES (August 17, 1994)
  • K935970 — FLOWGUN ELECTROCAUTERY PROBE HANDLE (May 16, 1994)
  • K935971 — FLOWGUN ELECTROCAUTERY PROBES (May 16, 1994)
  • K935645 — FLOWGUN REUSABLE IRRIGATION PROBES (March 7, 1994)
  • K926242 — ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE (October 15, 1993)
  • K922197 — INSUFFLATOR TUBING KIT (September 24, 1993)
  • K922244 — INSUFFLATOR TUBING/FILTER KIT (September 24, 1993)
  • K925147 — ORC 10.0MM SUCTION PROBE (June 25, 1993)
  • K925024 — ORC TAPPERED IRRIGATING PROBE (May 21, 1993)
  • K923908 — # 9455 AND #9457 POOLE TIP SUCTION PROBE (May 17, 1993)

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