Flexible Fiber-Optic Nasopharyngoscope
FDA 510(k) K895245 · Optimed Technologies, Inc.
510(k) numberK895245
Submission
- Device name
- Flexible Fiber-Optic Nasopharyngoscope
- Applicant
- Optimed Technologies, Inc.
Irvine, CA, US - Received
- August 21, 1989
- Decision date
- November 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K972520 | OptiviewLLZ · Traditional | 09/29/1997SE |
| K955276 | Booster Lite 4 Motorized ScooterINI · Traditional | 11/04/1996SE |
| K955275 | Booster Trophy 5 Motorized ScooterINI · Traditional | 11/04/1996SE |
| K955274 | Booster Lite 3 Motorized ScooterINI · Traditional | 11/04/1996SE |
| K943598 | Flexible Fiber Optic LaparoscopesHET · Traditional | 10/18/1994SE |
| K926597 | Laparoscope, Gynecologic (and Accessories)HET · Traditional | 07/12/1994SE |
| K921942 | Hysteroscope (and Accessories)HIH · Traditional | 06/24/1994SE |
| K922711 | Flexible Fiber Optic Gynecologic EndoscopeHIH · Traditional | 05/17/1994SE |
| K921985 | Arthroscope & AccessoriesHRX · Traditional | 06/29/1993SE |
| K922826 | Flexible Fiber Optic EndoscopeFGA · Traditional | 02/19/1993SE |
Questions and answers
When was Flexible Fiber-Optic Nasopharyngoscope cleared by the FDA?
Flexible Fiber-Optic Nasopharyngoscope (K895245) received a 510(k) decision of Substantially Equivalent on November 17, 1989, 88 days after the submission was received.
What is the product code of K895245?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.