Entellus Medical Flexible Endoscope and Eyepiece
FDA 510(k) K082569 · Entellus Medical, Inc.
510(k) numberK082569
Submission
- Device name
- Entellus Medical Flexible Endoscope and Eyepiece
- Applicant
- Entellus Medical, Inc.
Plymouth, MN, US - Received
- September 5, 2008
- Decision date
- September 18, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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).
Other 510(k)s with product code EOB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K220027 | Audion ET dilation systemPNZ · Traditional | 04/12/2022SE |
| K163509 | XprESS ENT Dilation SystemPNZ · Traditional | 04/05/2017SE |
| K163435 | Entellus Medical Reinforced Anesthesia NeedleBSP · Traditional | 04/05/2017SE |
| K152435 | PassAssist LED Light FiberLRC · Traditional | 11/20/2015SE |
| K152434 | XprESS Multi-Sinus Dilation SystemLRC · Traditional | 11/20/2015SE |
| K142252 | XprESS Multi-Sinus Dilation ToolLRC · Special | 10/17/2014SE |
| K141916 | Pathassist LED Light FiberLRC · Special | 08/07/2014SE |
| K133563 | Pathassist Light SeekerLRC · Special | 12/20/2013SE |
| K132440 | Xpress Multi-Sinus Dilation ToolLRC · Special | 10/04/2013SE |
| K130503 | Pathassist LED Light FiberLRC · Traditional | 06/11/2013SE |
Questions and answers
When was Entellus Medical Flexible Endoscope and Eyepiece cleared by the FDA?
Entellus Medical Flexible Endoscope and Eyepiece (K082569) received a 510(k) decision of Substantially Equivalent on September 18, 2008, 13 days after the submission was received.
What is the product code of K082569?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.