Bronchoscope (Flexible Or Rigid)
EOQ is the FDA product code for Bronchoscope (Flexible Or Rigid), a class II device type, regulated under 21 CFR 874.4680. FDA's definition for this code reads: "A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be...". As of , FDA records hold 241 510(k) clearances under this code, the most recent dated , and 160 recalls.
Classification record
- Product code
- EOQ
- Device name
- Bronchoscope (Flexible Or Rigid)
- FDA definition
- A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. 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 874.4680
- 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
- No
- Ingested clearances
- 244
- Ingested recalls
- 160
Clearances, product code EOQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 1 |
| 1979 | 2 |
| 1981 | 3 |
| 1982 | 4 |
| 1983 | 4 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 2 |
| 1987 | 2 |
| 1989 | 2 |
| 1990 | 3 |
| 1991 | 5 |
| 1992 | 5 |
| 1993 | 4 |
| 1994 | 10 |
| 1995 | 13 |
| 1996 | 15 |
| 1997 | 1 |
| 1998 | 7 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 4 |
| 2002 | 3 |
| 2003 | 5 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 3 |
| 2012 | 2 |
| 2013 | 4 |
| 2014 | 3 |
| 2015 | 6 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 7 |
| 2019 | 11 |
| 2020 | 10 |
| 2021 | 15 |
| 2022 | 11 |
| 2023 | 12 |
| 2024 | 13 |
| 2025 | 20 |
| 2026 | 9 |
Applicants with the most clearances
Product code EOQ| Applicant | Clearances |
|---|---|
| Olympus Medical Systems Corp. | 19 |
| Karl Storz Endoscopy-America, Inc. | 13 |
| PENTAX of America, Inc. | 12 |
| Intuitive Surgical, Inc. | 11 |
| Mill-Rose Laboratory | 11 |
| OLYMPUS Corporation of the Americas | 10 |
| Ambu A/S | 9 |
| Boston Scientific Corporation | 9 |
| Pentax Precision Instrument Corp. | 9 |
| FUJIFILM Healthcare Americas Corporation | 7 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
