Dr. Fog
FDA 510(k) K932449 · O.R. Concepts, Inc.
510(k) numberK932449
Submission
- Device name
- Dr. Fog
- Applicant
- O.R. Concepts, Inc.
Roanoke, TX, US - Received
- May 20, 1993
- Decision date
- August 11, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- OCT – Anti Fog Solution And Accessories, Endoscopy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
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|---|---|---|---|
| K251068 | KnoxFog Anti-fogging DeviceOCT · Traditional | Uv One Hygienics, Inc. | 08/27/2025SE |
| K231822 | GOLFF Sterile Anti-Fog SolutionOCT · Traditional | Batrik Medical Manufacturing, Inc. | 02/26/2024SE |
| K221293 | E-Brik Visualization AssistantOCT · Traditional | Jdi Surgical, Inc. | 07/07/2022SE |
| K190864 | Konix Anti-Fog SolutionOCT · Traditional | Turkuaz Saglik Hizmetleri Medikal Temizlik… | 08/27/2020SE |
| K181887 | AMD Anti-Fog SolutionOCT · Traditional | Advanced Medical Design Co., Ltd. | 01/22/2019SE |
| K163257 | VitreOx Anti-fog SolutionOCT · Traditional | Sio2 Nanotech, LLC | 05/24/2017SE |
| K152948 | Medline Anti-Fog SolutionOCT · Traditional | Medline Industries, Inc. | 02/04/2016SE |
| K120821 | Llics(Tm) Laparascopic Lens Internal Cleaning SystemOCT · Traditional | Misder, LLC | 05/11/2012SE |
| K111622 | Unimax Anti-Fog SolutionOCT · Traditional | Unimax Medical Systems, Inc. | 09/09/2011SE |
| K102452 | Defogging and Cleaning Solution- Flo-XOCT · Traditional | Minimally Invasive Devices, LLC | 12/23/2010SE |
More from Minimally Invasive Devices, LLC
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|---|---|---|
| K941337 | Flowgun Electrocautery ProbesGEI · Traditional | 08/17/1994SE |
| K935971 | Flowgun Electrocautery ProbesGEI · Traditional | 05/16/1994SE |
| K935970 | Flowgun Electrocautery Probe HandleGEI · Traditional | 05/16/1994SE |
| K935645 | Flowgun Reusable Irrigation ProbesGCJ · Traditional | 03/07/1994SE |
| K926242 | Orc Endoscopic Monopolar Electrosurgical ProbeGEI · Traditional | 10/15/1993SE |
| K922244 | Insufflator Tubing/Filter KitHIF · Traditional | 09/24/1993SE |
| K922197 | Insufflator Tubing KitHIG · Traditional | 09/24/1993SE |
| K925147 | Orc 10.0MM Suction ProbeGCJ · Traditional | 06/25/1993SE |
| K925024 | Orc Tappered Irrigating ProbeGCY · Traditional | 05/21/1993SE |
| K923908 | # 9455 and #9457 Poole Tip Suction ProbeGCY · Traditional | 05/17/1993SE |
Questions and answers
When was Dr. Fog cleared by the FDA?
Dr. Fog (K932449) received a 510(k) decision of Substantially Equivalent on August 11, 1993, 83 days after the submission was received.
What is the product code of K932449?
The FDA product code is OCT – Anti Fog Solution And Accessories, Endoscopy, a Class II (moderate risk) device regulated under 21 CFR 876.1500.