EOBClass II
Nasopharyngoscope (Flexible Or Rigid)
21 CFR 874.4760 / Ear, Nose, Throat
EOB is the FDA product code for Nasopharyngoscope (Flexible Or Rigid), a class II device type, regulated under 21 CFR 874.4760. FDA's definition for this code reads: "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)". As of , FDA records hold 162 510(k) clearances under this code, the most recent dated , and 8 recalls.
Classification record
- Product code
- EOB
- Device name
- Nasopharyngoscope (Flexible Or Rigid)
- FDA definition
- 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).
- Regulation
- 21 CFR 874.4760
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 163
- Ingested recalls
- 8
Clearances, product code EOB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 3 |
| 1992 | 3 |
| 1993 | 4 |
| 1994 | 12 |
| 1995 | 24 |
| 1996 | 9 |
| 1997 | 6 |
| 1998 | 4 |
| 1999 | 5 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 4 |
| 2003 | 6 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 4 |
| 2008 | 4 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 4 |
| 2012 | 1 |
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 3 |
| 2017 | 6 |
| 2018 | 6 |
| 2019 | 8 |
| 2020 | 3 |
| 2021 | 2 |
| 2022 | 6 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 3 |
| 2026 | 5 |
Applicants with the most clearances
Product code EOB| Applicant | Clearances |
|---|---|
| Karl Storz Endoscopy-America, Inc. | 29 |
| Cogentix Medical, Inc. | 15 |
| Olympus Medical Systems Corp. | 8 |
| PENTAX of America, Inc. | 6 |
| Acclarent Inc | 4 |
| 3NT Medical Ltd. | 3 |
| Ambu A/S | 3 |
| OLYMPUS Corporation of the Americas | 3 |
| Olympus Optical Co., Ltd. | 3 |
| Optim LLC | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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