Panels › Gastroenterology, Urology › Product code FDS · Class 2
Gastroscope And Accessories, Flexible/Rigid
Regulation 876.1500
8510(k)s in 12 months (79 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
Top companies in FDS
| Company | 510(k)s | Recalls |
|---|---|---|
| Fujifilm Corporation | 15 | 0 |
| Pentax Precision Instrument Corp. | 7 | 0 |
| Fujinon, Inc. | 5 | 1 |
| Pentax of America, Inc. | 5 | 1 |
| Olympus Medical Systems Corp. | 5 | 0 |
| Olympus Corporation of the Americas | 0 | 5 |
| EvoEndo, Inc. | 4 | 0 |
| Olympus Optical Co., Ltd. | 4 | 0 |
| Ambu A/S | 3 | 0 |
| Olympus America, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 2013 | K130148 | FOREIGN BODY HOOD United States Endoscopy Group, Inc. | FDS |
| Dec 11, 2012 | K123317 | EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N Olympus Medical Systems Corporation | FDS |
| Aug 13, 2012 | K120446 | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 Fujinon, Inc. | FDS |
| May 16, 2012 | K113166 | CLEARPATH UPPER GI Easyglide , Ltd. | FDS |
| May 16, 2011 | K111243 | FUJINON ULTRASONIC PROCESSOR Fujinon, Inc. | FDS |
| Mar 9, 2010 | K093779 | CLEARPATH UGI Easyglide , Ltd. | FDS |
| Mar 16, 2007 | K063316 | FUJINON MODEL EG-530N TRANS NASAL INSERTION Fujinon, Inc. | FDS |
| Mar 1, 2007 | K063847 | FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 Fujinon, Inc. | FDS |
| Nov 9, 2006 | K060907 | KARL STORZ VIDEO GASTROSCOPES KARL STORZ Endoscopy-America, Inc. | FDS |
| Nov 24, 2004 | K042043 | FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 Fujinon, Inc. | FDS |
| Oct 2, 2003 | K032177 | GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I Olympus Opto-Electronics Co., Ltd. | FDS |
| Jun 19, 2002 | K021886 | OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P Olympus Optical Co., Ltd. | FDS |
| Feb 4, 2002 | K013640 | EG-3630UR, ULTRASUND VIDEO GASTROSCOPE Pentax Precision Instrument Corp. | FDS |
| May 15, 2001 | K011151 | EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z The Olympus Optical Co. | FDS |
| Jan 30, 2001 | K002231 | LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT Olympus Optical Co., Ltd. | FDS |
| Sep 8, 2000 | K001766 | OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE Olympus Optical Co., Ltd. | FDS |
| Sep 17, 1999 | K984358 | OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 Olympus America, Inc. | FDS |
| Mar 31, 1998 | K974493 | FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES Fiegert-Endotech Medizintechnik GmbH, DE | FDS |
| Jul 29, 1997 | K971734 | VG 200 VIDEO GASTROSCOPE Welch Allyn, Inc. | FDS |
| Jul 25, 1997 | K971660 | OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT Olympus America, Inc. | FDS |
| Feb 7, 1997 | K963023 | ULTRASOUND GASTROSCOPE GF TYPE UM30P Olympus America, Inc. | FDS |
| Oct 4, 1996 | K962897 | EG-3400, VIDEO GASTROSCOPE Pentax Precision Instrument Corp. | FDS |
| Sep 16, 1996 | K962460 | EG-3800T, VIDEO GASTROSCOPE Pentax Precision Instrument Corp. | FDS |
| Jul 9, 1996 | K961564 | EG-2940, VIDEO GASTROSCOPE Pentax Precision Instrument Corp. | FDS |
| Feb 24, 1995 | K943715 | VISION SYSTEM UPPER G.I. EXDOSCOPE Vision-Sciences, Inc. | FDS |
| Nov 2, 1993 | K933717 | OLYMPUS MEASURING DEVICES Olympus Corp. | FDS |
| Jul 9, 1985 | K850020 | PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23 Pentax Precision Instrument Corp. | FDS |
| Feb 4, 1984 | K833924 | TWO CHANNEL GASTROFIBERSCOPE FG-36T Pentax Precision Instrument Corp. | FDS |
| Aug 11, 1983 | K832007 | PENTAX FG-34JA GASTROFIBERSCOPE Pentax Precision Instrument Corp. | FDS |
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