FDA product code FBO: Cystourethroscope
FBO is the FDA product code for cystourethroscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 19 510(k) submissions under FBO, 2 in the last five years, from 13 different applicants. The average 510(k) review took 160 days (median 127); 76 days on average over the last three years. FDA has posted 7 recalls for FBO devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cystourethroscope |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for FBO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 26 |
| 2025 | 1 | 127 |
Compare with all 510(k) review times · Search every FBO clearance
Top FBO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 5 | 2014-01-02 |
| Karl Storz SE & CO. KG | 2 | 2025-05-02 |
| Richard Wolf Medical Instruments Corp. | 2 | 2001-08-10 |
| Epitek, Inc. | 1 | 2008-07-30 |
| Laserscope | 1 | 2006-06-27 |
8 more applicants have FBO clearances. See the full list in Caduvo.
Most recent FBO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K244001 | Karl Storz SE & CO. KG | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) | 2025-05-02 | 127 |
| K243409 | Karl Storz SE & CO. KG | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) | 2024-11-27 | 26 |
| K131364 | KARL STORZ Endoscopy-America, Inc. | FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE | 2014-01-02 | 234 |
| K082046 | KARL STORZ Endoscopy-America, Inc. | KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO | 2008-10-10 | 84 |
| K080780 | Epitek, Inc. | ANCHORAGE SCOPE, MODEL 000003 | 2008-07-30 | 133 |
Recalls for FBO devices
7 product recalls in 3 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2023-09-25.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2022 | 5 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code FBO?
FBO is the FDA product code for cystourethroscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FBO?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FBO?
Across 19 cleared submissions the average was 160 days from receipt to decision (median 127).
Which companies have the most FBO clearances?
KARL STORZ Endoscopy-America, Inc. (5); Karl Storz SE & CO. KG (2); Richard Wolf Medical Instruments Corp. (2); Epitek, Inc. (1); Laserscope (1).
Have FBO devices been recalled?
Yes: 7 product recalls across 3 recall events; the most recent began 2023-09-25.
Next steps
- Run an FDA pathway report with predicate devices for product code FBO
- Run a recall and safety report across every FBO manufacturer
- Watch product code FBO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times