FDA product code FAJ: Cystoscope And Accessories, Flexible/Rigid
FAJ is the FDA product code for cystoscope and accessories, flexible/rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 92 510(k) submissions under FAJ, 32 in the last five years, from 62 different applicants. The average 510(k) review took 128 days (median 122); 124 days on average over the last three years. FDA has posted 22 recalls for FAJ devices, 10 initiated in the last five years.
Definition
To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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).
Classification
| Field | Value |
|---|---|
| Device name | Cystoscope And Accessories, Flexible/Rigid |
| 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 FAJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 242 |
| 2018 | 2 | 141 |
| 2019 | 3 | 197 |
| 2020 | 2 | 88 |
| 2021 | 3 | 124 |
| 2022 | 5 | 157 |
| 2023 | 5 | 195 |
| 2024 | 9 | 149 |
| 2025 | 8 | 110 |
| 2026 | 5 | 114 |
Compare with all 510(k) review times · Search every FAJ clearance
Top FAJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Uroviu Corporation | 7 | 2025-10-23 |
| KARL STORZ Endoscopy-America, Inc. | 7 | 2020-10-29 |
| Ambu A/S | 5 | 2025-06-11 |
| Guangzhou Red Pine Medical Instrument Co., Ltd. | 3 | 2025-08-08 |
| Vision-Sciences, Inc. | 3 | 2007-12-18 |
57 more applicants have FAJ clearances. See the full list in Caduvo.
Most recent FAJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260649 | Olympus Winter & Ibe GmbH | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, | 2026-05-21 | 83 |
| K253696 | Verathon Medical (Canada) Ulc | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) | 2026-05-11 | 171 |
| K253892 | Strauss Surgical USA | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°, | 2026-04-16 | 133 |
| K253905 | Cogentix Medical, Inc. | PrimeSight UltraView System | 2026-04-07 | 123 |
| K260271 | American Medical Endoscopy, Inc. | Strauss Surgical cystoscope, hysteroscope and accessories Instruments | 2026-03-27 | 58 |
Recalls for FAJ devices
22 product recalls in 10 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2023-12-04.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 7 |
| 2022 | 3 |
| 2023 | 7 |
Frequently asked questions
What is FDA product code FAJ?
FAJ is the FDA product code for cystoscope and accessories, flexible/rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FAJ?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FAJ?
Across 92 cleared submissions the average was 128 days from receipt to decision (median 122).
Which companies have the most FAJ clearances?
Uroviu Corporation (7); KARL STORZ Endoscopy-America, Inc. (7); Ambu A/S (5); Guangzhou Red Pine Medical Instrument Co., Ltd. (3); Vision-Sciences, Inc. (3).
Have FAJ devices been recalled?
Yes: 22 product recalls across 10 recall events; the most recent began 2023-12-04.
Next steps
- Run an FDA pathway report with predicate devices for product code FAJ
- Run a recall and safety report across every FAJ manufacturer
- Watch product code FAJ 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.
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