Clarus Murphypen ENDOSCOPE(2127-XXX)
FDA 510(k) K962255 · Clarus Medical Systems, Inc.
510(k) numberK962255
Submission
- Device name
- Clarus Murphypen ENDOSCOPE(2127-XXX)
- Applicant
- Clarus Medical Systems, Inc.
Minneapolis, MN, US - Received
- June 12, 1996
- Decision date
- September 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 |
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| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K980588 | Clarus Endoscopic Discectomy System Sitetrac Model 6000GAD · Traditional | 08/18/1998SE |
| K974579 | Percscope Model 2600HRX · Traditional | 02/18/1998SE |
| K971584 | Clarus Model 2127-900 Series Endoscope Adater (2127-900 Series)OCV · Traditional | 05/23/1997SE |
| K971455 | Clarus Model 5197 SightliteFTI · Traditional | 05/20/1997SE |
| K960915 | Clarus Neuropen Endoscopic Placement Kit Model 2125-XXXGWG · Traditional | 12/24/1996SE |
| K955598 | Clarus Spinepen Model 2126GWG · Traditional | 02/06/1996SE |
| K953685 | Instrument ScopeGWG · Traditional | 10/12/1995SE |
| K945633 | Neuro Channel Endoscope Model 2232GWG · Traditional | 09/19/1995SE |
| K945296 | Clarus Phoenix Neuro Endoscope Model 2160GWG · Traditional | 07/14/1995SE |
| K941188 | Clarus Neuro Endoscope (Model 2230)HRX · Traditional | 04/25/1995SE |
Questions and answers
When was Clarus Murphypen ENDOSCOPE(2127-XXX) cleared by the FDA?
Clarus Murphypen ENDOSCOPE(2127-XXX) (K962255) received a 510(k) decision of Substantially Equivalent on September 11, 1996, 91 days after the submission was received.
What is the product code of K962255?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.