FDA product code GCT: Light Source, Endoscope, Xenon Arc
GCT is the FDA product code for light source, endoscope, xenon arc. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 47 510(k) submissions under GCT, from 35 different applicants. The average 510(k) review took 94 days (median 78). FDA has posted 3 recalls for GCT devices.
Classification
| Field | Value |
|---|---|
| Device name | Light Source, Endoscope, Xenon Arc |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GCT clearance
Top GCT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 4 | 2008-12-18 |
| Richard Wolf Medical Instruments Corp. | 4 | 1998-12-11 |
| World of Medicine Lemke GmbH | 3 | 2003-01-14 |
| Contec Medical Vision, Ltd. | 2 | 1998-09-23 |
| Welch Allyn, Inc. | 2 | 1998-02-27 |
30 more applicants have GCT clearances. See the full list in Caduvo.
Most recent GCT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093125 | Gimmi GmbH | ALPHAXENON LIGHT 180 W AND 300 W | 2010-01-27 | 117 |
| K082925 | KARL STORZ Endoscopy-America, Inc. | XENON-100 SCB LIGHT SOURCE, MODEL 20132620 | 2008-12-18 | 78 |
| K070376 | Conmed Linvatec | CONMED LINVATEC 300W XENON LIGHT SOURCE | 2007-08-20 | 193 |
| K040949 | Acueity, Inc. | VIADUCT MINISCOPE AND ACCESSORIES | 2004-05-07 | 25 |
| K022490 | KARL STORZ Endoscopy-America, Inc. | KSEA MEDI PACK | 2003-09-29 | 427 |
Recalls for GCT devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-05-20.
Frequently asked questions
What is FDA product code GCT?
GCT is the FDA product code for light source, endoscope, xenon arc. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is GCT?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GCT?
Across 47 cleared submissions the average was 94 days from receipt to decision (median 78).
Which companies have the most GCT clearances?
KARL STORZ Endoscopy-America, Inc. (4); Richard Wolf Medical Instruments Corp. (4); World of Medicine Lemke GmbH (3); Contec Medical Vision, Ltd. (2); Welch Allyn, Inc. (2).
Have GCT devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2011-05-20.
Next steps
- Run an FDA pathway report with predicate devices for product code GCT
- Run a recall and safety report across every GCT manufacturer
- Watch product code GCT 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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