# Olympus Medical Systems Corp.

- Location (FDA's records): Hachioji-Shi, JP
- FDA decisions: 190 (2004–2026): 190 510(k) clearances
- Names in FDA's records: Olympus Medical Systems Corp. (104); Olympus Medical Systems Corporation (86)
- Product codes: EOQ (19), KNS (10), FET (10), FDT (8), GEI (8), EOB (8), GCJ (8), FDF (7), NEZ (7), FCG (7), IYN (6), HET (6)
- 510(k) review time since 2016: median 133 days, against 147 for FDA's reviews in the same codes and years (37 of 84 faster)
- Predicates its devices cite: 305 (144 its own); citations of its devices by later devices: 251 (144 its own)
- Recalls linked to its devices: 300 (24 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Olympus Optical Co., Ltd.: 33 (https://510kreport.com/company/olympus-optical)
- Olympus America, Inc.: 25 (https://510kreport.com/company/olympus-america)
- Olympus Corp.: 10 (https://510kreport.com/company/olympus)
- Boston Scientific Corp: 8 (https://510kreport.com/company/boston-scientific)
- Olympus Winter & Ibe GmbH: 7 (https://510kreport.com/company/olympus-winter-ibe)
- Given Imaging, Ltd.: 6 (https://510kreport.com/company/given-imaging)
- Aomori Olympus Co., Ltd.: 5 (https://510kreport.com/company/aomori-olympus)
- Aloka Co., Ltd.: 5 (https://510kreport.com/company/aloka)

## Firms that cite its devices most
- Boston Scientific Corp: 8 (https://510kreport.com/company/boston-scientific)
- Pentax Medical Company: 6 (https://510kreport.com/company/pentax-medical)
- Ambu A/S: 5 (https://510kreport.com/company/ambu-a-s)
- Fujifilm Corporation: 4 (https://510kreport.com/company/fujifilm)
- Fujifilm Medical System U.S.A., Inc.: 4 (https://510kreport.com/company/fujifilm-medical-system-usa)
- Finemedix Co., Ltd.: 3 (https://510kreport.com/company/finemedix)
- Hangzhou AGS MedTech Co., Ltd.: 3 (https://510kreport.com/company/hangzhou-ags-medtech)
- Pentax of America, Inc.: 3 (https://510kreport.com/company/pentax-of-america)

## Its most-cited devices
- K100584: Evis Exeraii 180 System (2010), cited by 22
- K061313: Evis Exera 180 System (2006), cited by 10
- K051645: Evis Exera 160A System (2005), cited by 9
- K092309: Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L (2009), cited by 7
- K111425: Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 (2012), cited by 6
- K171158: Single Use Electrosurgical knife (2017), cited by 6

## Recent decisions
- K262079: 4K Camera Head OLYMPUS CH-S700-08-LB (Sep 10, 2026)
- K260824: Gastrointestinal Videoscope Olympus GIF-2T1500 (Aug 27, 2026)
- K260401: Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F) (Aug 27, 2026)
- K260856: Disposable Distal Attachment D-201-13404 (Aug 27, 2026)
- K261183: EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (Jul 31, 2026)
- K254056: THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) (Jul 1, 2026)
- K261260: HD Camera Head OLYMPUS CH-S200-08-LB (Jun 24, 2026)
- K260580: Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) (May 21, 2026)

Source page: https://510kreport.com/company/olympus-medical-systems