Citation Sinuscope
FDA 510(k) K951249 · Citation Medical Corp.
510(k) numberK951249
Submission
- Device name
- Citation Sinuscope
- Applicant
- Citation Medical Corp.
Reno, NV, US - Received
- March 20, 1995
- Decision date
- April 10, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EOB – Nasopharyngoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K261544 | Hydro Irrigation SystemEOB · Traditional | Stryker Instruments | 06/17/2026SE |
| K254133 | ENTity USB Videoscope SystemEOB · Traditional | Optim, LLC | 05/14/2026SE |
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…EOB · Traditional | Zhuhai Wesee Meditech Co., Ltd. | 03/25/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | Olympus Medical Systems Corporation | 03/20/2026SE |
| K241731 | Outlook Surgical Versa One System (8900139)EOB · Traditional | Resnent, LLC | 08/11/2025SE |
| K243639 | Portare System (FA-001)EOB · Traditional | Grumpy Innovation, Inc. | 06/05/2025SE |
| K243380 | Visera S Video System Center Olympus OTV-S500 (Olympus OTV-S500)EOB · Traditional | Olympus Medical Systems Corporation | 03/03/2025SE |
| K234096 | MonoStereoEOB · Traditional | Medicaltek Co., Ltd. | 09/19/2024SE |
| K232435 | Rhinolaryngoscope systemEOB · Traditional | Shenzhen HugeMed Medical Technical Development… | 04/26/2024SE |
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)EOB · Traditional | Atmos Medizintechnik GmbH & Co. KG | 08/03/2023SE |
More from Atmos Medizintechnik GmbH & Co. KG
| 510(k) | Device | Decision |
|---|---|---|
| K951941 | Citation Multiple Use Delta ScopeHRX · Traditional | 07/14/1995SE |
| K945390 | Citation Delta ScopeHRX · Traditional | 06/23/1995SE |
| K946290 | Citation Power ToolHRX · Traditional | 06/15/1995SE |
| K944976 | Bronchoscope,Non-RigidEOQ · Traditional | 12/21/1994SE |
| K940847 | Endoscopic Plantar Fascia KitHRX · Traditional | 10/11/1994SE |
| K941563 | The Biopsy ToolFCG · Traditional | 09/26/1994SE |
| K924494 | Citscope, Bendable -- ModificationHRX · Traditional | 05/26/1993SN |
| K922144 | Citscope (Model Extensions)HRX · Traditional | 08/05/1992SE |
| K921692 | Integrated Video SystemHRX · Traditional | 07/01/1992SE |
| K912490 | Citation Medical Scope Procedure PackKKX · Traditional | 08/16/1991SE |
Questions and answers
When was Citation Sinuscope cleared by the FDA?
Citation Sinuscope (K951249) received a 510(k) decision of Substantially Equivalent on April 10, 1995, 21 days after the submission was received.
What is the product code of K951249?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.