Panels › Gastroenterology, Urology › Product code GCT · Class 2
Light Source, Endoscope, Xenon Arc
Regulation 876.1500
0510(k)s in 12 months (47 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in GCT
| Company | 510(k)s | Recalls |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 4 | 0 |
| Richard Wolf Medical Instruments Corp. | 4 | 0 |
| World of Medicine Lemke GmbH | 3 | 0 |
| Cogent Light Technologies, Inc. | 2 | 0 |
| Contec Medical Vision, Ltd. | 2 | 0 |
| Laser Optik Systeme GmbH & Co. KG | 2 | 0 |
| Linvatec Corp. dba ConMed Linvatec | 0 | 2 |
| Pentax Precision Instrument Corp. | 2 | 0 |
| Welch Allyn, Inc. | 2 | 0 |
| Acueity, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2012 | Linvatec Corp. dba ConMed Linvatec ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source Terminated |
GCT | K070376 |
| Sep 25, 2012 | Linvatec Corp. dba ConMed Linvatec ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source Terminated |
GCT | K070376 |
| Sep 10, 2005 | Linvatec Imaging Linvatec LS 7500, 300 Watt Xenon Light Source
Catalog Numbers: LS7500, LS7500L (loaner),
LS7500R (refurbished) Terminated |
GCT | K031994 |
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