FDA Product Code
FDA Product Code GCT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 47 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K093125 | ALPHAXENON LIGHT 180 W AND 300 W | Gimmi GmbH | 2010-01-27 | Abbreviated | PDF ↗ |
| K082925 | XENON-100 SCB LIGHT SOURCE, MODEL 20132620 | KARL STORZ Endoscopy-America, Inc. | 2008-12-18 | Traditional | PDF ↗ |
| K070376 | CONMED LINVATEC 300W XENON LIGHT SOURCE | Conmed Linvatec | 2007-08-20 | Traditional | PDF ↗ |
| K040949 | VIADUCT MINISCOPE AND ACCESSORIES | Acueity, Inc. | 2004-05-07 | Traditional | PDF ↗ |
| K022490 | KSEA MEDI PACK | KARL STORZ Endoscopy-America, Inc. | 2003-09-29 | Traditional | PDF ↗ |
| K031994 | LINVATEC 300W XENON LIGHT SOURCE | Linvatec Corp. | 2003-08-21 | Traditional | PDF ↗ |
| K023468 | ENDOSCOPIC LIGHT SOURCE XL180/L3 | World of Medicine Lemke GmbH | 2003-01-14 | Traditional | PDF ↗ |
| K021717 | ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 | World of Medicine Lemke GmbH | 2002-08-20 | Traditional | PDF ↗ |
| K020889 | ENDOSCOPIC LIGHT SOURCE XL202/L3 | World of Medicine Lemke GmbH | 2002-06-05 | Traditional | PDF ↗ |
| K013880 | DAYLITE XENON LIGHT SOURCES | Designs For Vision, Inc. | 2001-12-07 | Traditional | PDF ↗ |
| K992050 | LUMENON XENON LIGHT SOURCE | Walter Lorenz Surgical, Inc. | 1999-09-14 | Traditional | PDF ↗ |
| K992540 | XENON LIGHT SOURCE PES 1 | Laser Optik Systeme GmbH & Co. KG | 1999-09-14 | Traditional | PDF ↗ |
| K983628 | XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011 | Richard Wolf Medical Instruments Corp. | 1998-12-11 | Traditional | PDF ↗ |
| K982962 | XENON LIGHT SOURCE, MODELS LS6180, LS6035 | Contec Medical Vision, Ltd. | 1998-09-23 | Traditional | PDF ↗ |
| K981804 | XENON LIGHT SOURCE MODEL LS6000 | Contec Medical Vision, Ltd. | 1998-07-24 | Traditional | PDF ↗ |
| K980281 | WELCH ALLYN XENON 300 LIGHT SOURCE | Welch Allyn, Inc. | 1998-02-27 | Traditional | PDF ↗ |
| K971057 | COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM | Cogent Light Technologies, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K963227 | WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 | Products For Medicine | 1996-10-23 | Traditional | PDF ↗ |
| K963044 | ENDOBEAM | Corin USA | 1996-09-20 | Traditional | PDF ↗ |
| K962365 | XENON LIGHTSOURCE | Dsp Worldwide | 1996-07-18 | Traditional | PDF ↗ |
| K954561 | XENON NOPPVA | KARL STORZ Endoscopy-America, Inc. | 1995-10-19 | Traditional | PDF ↗ |
| K953924 | XLS-300 XENON LIGHT SOURCE | Specialties of Surgery | 1995-09-21 | Traditional | PDF ↗ |
| K952028 | COLD LIGHT SOURCE LOS XL-A 100 | Laser-Optik-Systeme GmbH & Co. KG | 1995-07-27 | Traditional | PDF ↗ |
| K952563 | THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM | The Tulip Mfg. Co. | 1995-07-25 | Traditional | PDF ↗ |
| K952696 | XENON LIGHT SOURCE MODEL 5121 | Richard Wolf Medical Instruments Corp. | 1995-07-25 | Traditional | PDF ↗ |
| K951971 | XENON LIGHT SOURCE | Envision Medical Corp. | 1995-05-24 | Traditional | PDF ↗ |
| K951895 | ACCU-BEAM 300W XENON LIGHT SOURCE | Tti Medical | 1995-05-24 | Traditional | PDF ↗ |
| K944607 | MODEL 5135 AUTO LP/FLASH | Richard Wolf Medical Instruments Corp. | 1994-12-13 | Traditional | PDF ↗ |
| K944821 | MODEL 5151 | Richard Wolf Medical Instruments Corp. | 1994-11-14 | Traditional | PDF ↗ |
| K934559 | KARL STORZ XENON LIGHT SOURCE MODEL 201320-20 | KARL STORZ Endoscopy-America, Inc. | 1994-04-22 | Traditional | PDF ↗ |
| K940270 | LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM | Welch Allyn, Inc. | 1994-04-20 | Traditional | PDF ↗ |
| K936198 | ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES | Carl Zeiss, Inc. | 1994-04-06 | Traditional | PDF ↗ |
| K933405 | COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE | Cogent Light Technologies, Inc. | 1994-02-18 | Traditional | PDF ↗ |
| K935423 | COOL LIGHT 300 | Endosurgical Development Corp. | 1994-01-26 | Traditional | PDF ↗ |
| K933868 | ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES | Angiolaz, Inc. | 1993-11-10 | Traditional | PDF ↗ |
| K932281 | VERRES NEEDLE | Surgeon Surgical Instrumentation, Inc. | 1993-08-06 | Traditional | PDF ↗ |
| K924897 | XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 | Medical Devices, Inc. | 1993-07-06 | Traditional | PDF ↗ |
| K921315 | PENTAX XENON LIGHT SOURCE | Pentax Precision Instrument Corp. | 1993-06-25 | Traditional | PDF ↗ |
| K923210 | SYSTEM 3000 XENON VIDEOLAP LIGHT | Cabot Medical Corp. | 1992-10-05 | Traditional | PDF ↗ |
| K921390 | XENON LIGHT SOURCE AND ACCESSORIES | Coopervision Surgical | 1992-07-27 | Traditional | PDF ↗ |
| K913586 | MARLOW VERRES NEEDLES | Marlo Surgical Technology | 1991-10-08 | Traditional | PDF ↗ |
| K912354 | OLYMOUS XLS XENON LIGHT SOURCE | Perkinelmer Optoelectronics | 1991-08-16 | Traditional | PDF ↗ |
| K911492 | ENDOSCOPIC LIGHT SOURCE | United States Endoscopy Group, Inc. | 1991-08-14 | Traditional | PDF ↗ |
| K905282 | ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE | Frantz Medical Development, Ltd. | 1991-03-19 | Traditional | PDF ↗ |
| K905124 | MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE | Red Wing Imaging, Inc. | 1991-01-25 | Traditional | PDF ↗ |
| K864801 | THE KEYMED HI-LIGHT 250 LIGHT SOURCE | Keymed, Inc. | 1986-12-24 | Traditional | PDF ↗ |
| K792215 | PENTEX UPPER G.I. SCOPE MODEL FG-28A | Pentax Precision Instrument Corp. | 1979-12-10 | Traditional | PDF ↗ |
Product code GCT · Class II · Gastroenterology, Urology. Data: openFDA.