Slide-On Endosheath System for Sensory Testing
FDA 510(k) K031790 · Vision-Sciences, Inc.
510(k) numberK031790
Submission
- Device name
- Slide-On Endosheath System for Sensory Testing
- Applicant
- Vision-Sciences, Inc.
Ayer, MA, US - Received
- June 10, 2003
- Decision date
- July 2, 2003
- 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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| 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 |
|---|---|---|
| K102733 | Vision-Sciences ENT-5000 Video ENT Scope with Endosheath Technology, Vision-Sciences…EOB · Traditional | 05/18/2011SE |
| K100125 | Vision Sciences Flexible ENT ScopeEOB · Special | 02/25/2010SE |
| K091768 | Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, DPU-5000/DPU-5050…EOQ · Traditional | 08/03/2009SE |
| K072180 | Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemFAJ · Traditional | 12/18/2007SE |
| K071127 | Flexible Hysteroscope with Endosheath SystemHIH · Traditional | 11/16/2007SE |
| K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…EOX · Special | 08/29/2007SE |
| K072073 | Vision-Sciences ENT-5000 and ENT-5100 Video ENT Scope with Endosheath System…EOB · Special | 08/29/2007SE |
| K071903 | Endosheath Systems for Use with Vision-Sciences Tne ScopeEOX · Special | 08/02/2007SE |
| K053560 | Modified Endosheath System for Vsi Flexible CystoscopeFAJ · Special | 03/16/2006SE |
| K050972 | Vision-Sciences ENT-3000 ScopeEOB · Special | 04/29/2005SE |
Questions and answers
When was Slide-On Endosheath System for Sensory Testing cleared by the FDA?
Slide-On Endosheath System for Sensory Testing (K031790) received a 510(k) decision of Substantially Equivalent on July 2, 2003, 22 days after the submission was received.
What is the product code of K031790?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.