FDA product code FGA: Kit, Nephroscope
FGA is the FDA product code for kit, nephroscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 10 510(k) submissions under FGA, 1 in the last five years, from 8 different applicants. The average 510(k) review took 137 days (median 132); 267 days on average over the last three years. FDA has posted 8 recalls for FGA devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Nephroscope |
| 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 FGA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 267 |
Compare with all 510(k) review times · Search every FGA clearance
Top FGA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Richard Wolf Medical Instruments Corp. | 2 | 2000-06-05 |
| KARL STORZ Endoscopy-America, Inc. | 2 | 1995-03-15 |
| Karl Storz SE & CO. KG | 1 | 2024-05-01 |
| Schoelly Fiberoptic GmbH | 1 | 2016-02-09 |
| Gyrus Acmi, Inc. | 1 | 2007-12-13 |
3 more applicants have FGA clearances. See the full list in Caduvo.
Most recent FGA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232370 | Karl Storz SE & CO. KG | Percutaneous Nephroscope System | 2024-05-01 | 267 |
| K151308 | Schoelly Fiberoptic GmbH | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | 2016-02-09 | 267 |
| K072594 | Gyrus Acmi, Inc. | GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM | 2007-12-13 | 90 |
| K994223 | Richard Wolf Medical Instruments Corp. | NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 | 2000-06-05 | 173 |
| K950433 | KARL STORZ Endoscopy-America, Inc. | KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES | 1995-03-15 | 41 |
Recalls for FGA devices
8 product recalls in 1 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2024-07-23.
| Year | Recalls |
|---|---|
| 2024 | 8 |
Frequently asked questions
What is FDA product code FGA?
FGA is the FDA product code for kit, nephroscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FGA?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FGA?
Across 10 cleared submissions the average was 137 days from receipt to decision (median 132).
Which companies have the most FGA clearances?
Richard Wolf Medical Instruments Corp. (2); KARL STORZ Endoscopy-America, Inc. (2); Karl Storz SE & CO. KG (1); Schoelly Fiberoptic GmbH (1); Gyrus Acmi, Inc. (1).
Have FGA devices been recalled?
Yes: 8 product recalls across 1 recall events; the most recent began 2024-07-23.
Next steps
- Run an FDA pathway report with predicate devices for product code FGA
- Run a recall and safety report across every FGA manufacturer
- Watch product code FGA 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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