FDA product code FGO: Dislodger, Stone, Flexible
FGO is the FDA product code for dislodger, stone, flexible. It is a Class II device, regulated under 21 CFR 876.4680 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 19 510(k) submissions under FGO, from 11 different applicants. The average 510(k) review took 146 days (median 163). FDA has posted 3 recalls for FGO devices.
Classification
| Field | Value |
|---|---|
| Device name | Dislodger, Stone, Flexible |
| Device class | Class II |
| Regulation | 21 CFR 876.4680 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FGO clearance
Top FGO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corp | 4 | 1997-04-02 |
| Annex Medical, Inc. | 4 | 1994-01-07 |
| Surgitek | 2 | 1994-01-11 |
| Northgate Research, Inc. | 2 | 1989-03-22 |
| Scion Cardiovascular, Inc. | 1 | 2000-11-22 |
6 more applicants have FGO clearances. See the full list in Caduvo.
Most recent FGO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K001563 | Scion Cardiovascular, Inc. | SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET | 2000-11-22 | 187 |
| K970121 | Boston Scientific Corp | STONE DISLODGER, BASKET | 1997-04-02 | 78 |
| K963750 | Boston Scientific Corp | RETRIEVAL SNARE | 1996-11-22 | 65 |
| K962676 | United States Endoscopy Group, Inc. | DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE | 1996-10-04 | 87 |
| K951309 | Boston Scientific Corp | STONE DISLODGER, BASKET | 1995-05-17 | 56 |
Recalls for FGO devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-11-14.
Frequently asked questions
What is FDA product code FGO?
FGO is the FDA product code for dislodger, stone, flexible. It is a Class II device, regulated under 21 CFR 876.4680 and reviewed by the Gastroenterology and Urology panel.
What device class is FGO?
Class II, regulation 21 CFR 876.4680. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FGO?
Across 19 cleared submissions the average was 146 days from receipt to decision (median 163).
Which companies have the most FGO clearances?
Boston Scientific Corp (4); Annex Medical, Inc. (4); Surgitek (2); Northgate Research, Inc. (2); Scion Cardiovascular, Inc. (1).
Have FGO devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2011-11-14.
Next steps
- Run an FDA pathway report with predicate devices for product code FGO
- Run a recall and safety report across every FGO manufacturer
- Watch product code FGO 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