ENTity USB Videoscope System
FDA 510(k) K254133 · Optim, LLC
510(k) numberK254133
Submission
- Device name
- ENTity USB Videoscope System
- Applicant
- Optim, LLC
Sturbridge, MA, US - Received
- December 22, 2025
- Decision date
- May 14, 2026
- 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).
Other 510(k)s with product code EOB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261544 | Hydro Irrigation SystemEOB · Traditional | Stryker Instruments | 06/17/2026SE |
| 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 |
| K222587 | PatCom Distal Chip EndoscopeEOB · Traditional | H&A Mui Enterprises, Inc. | 07/28/2023SE |
More from H&A Mui Enterprises, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200609 | ENTity WiFi Video Nasopharyngoscope SystemEOB · Traditional | 01/13/2021SE |
| K130489 | Electrode, Flexible Suction CoagulatorFEH · Special | 04/19/2013SE |
| K122593 | Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide…FEH · Special | 09/13/2012SE |
| K091829 | PLS Portable Light SourceNTN · Abbreviated | 07/28/2009SE |
| K080622 | Entity Nasoview LED Nasopharyngoscope, Model 006105EOB · Special | 04/02/2008SE |
Questions and answers
When was ENTity USB Videoscope System cleared by the FDA?
ENTity USB Videoscope System (K254133) received a 510(k) decision of Substantially Equivalent on May 14, 2026, 143 days after the submission was received.
What is the product code of K254133?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.