# Olympus Optical Co., Ltd.

- Location (FDA's records): Melville, NY
- FDA decisions: 48 (1996–2003): 48 510(k) clearances
- Names in FDA's records: Olympus Optical Co., Ltd. (22); The Olympus Optical Co. (22); Olympus Optical, Co. (4)
- Product codes: LFL (5), EOQ (4), FDS (4), GEI (4), ODG (3), ITX (3), EOB (3), FDF (2), GWG (2), ODA (2), PKL (1), FCL (1)
- Predicates its devices cite: 106 (21 its own); citations of its devices by later devices: 131 (21 its own)
- Recalls linked to its devices: 67 (15 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Olympus America, Inc.: 38 (https://510kreport.com/company/olympus-america)
- Olympus Corp.: 16 (https://510kreport.com/company/olympus)
- Valleylab, Inc.: 4 (https://510kreport.com/company/valleylab)
- Pentax Precision Instrument Corp.: 3 (https://510kreport.com/company/pentax-precision-instrument)
- Ethicon Endo-Surgery, Inc.: 3 (https://510kreport.com/company/ethicon-endo-surgery)
- Sofamor Danek USA,Inc.: 3 (https://510kreport.com/company/sofamor-danek-usa)
- Advanced Technology Laboratories, Inc.: 2 (https://510kreport.com/company/advanced-technology-laboratories)
- Ultracision, Inc.: 2 (https://510kreport.com/company/ultracision)

## Firms that cite its devices most
- Olympus Medical Systems Corp.: 33 (https://510kreport.com/company/olympus-medical-systems)
- Aomori Olympus Co., Ltd.: 12 (https://510kreport.com/company/aomori-olympus)
- Olympus America, Inc.: 11 (https://510kreport.com/company/olympus-america)
- Olympus Corp.: 8 (https://510kreport.com/company/olympus)
- Ambu A/S: 5 (https://510kreport.com/company/ambu-a-s)
- Boston Scientific Corp: 4 (https://510kreport.com/company/boston-scientific)
- Olympus Winter & Ibe GmbH: 3 (https://510kreport.com/company/olympus-winter-ibe)
- Gyrus Acmi, Inc.: 2 (https://510kreport.com/company/gyrus-acmi)

## Its most-cited devices
- K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I (2000), cited by 15
- K023984: Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 Series (2003), cited by 9
- K972114: Olympus Sonosurg System (1998), cited by 8
- K981543: Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment (1998), cited by 7
- K013591: Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment (2001), cited by 7
- K000095: Olympus Sonosurg Trocar XT3900 System (2000), cited by 6

## Recent decisions
- K033225: Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary Equipment (Oct 16, 2003)
- K032066: Sonosurg System (Oct 3, 2003)
- K031305: Olympus Ultrasonic Surgical System (Sep 23, 2003)
- K031648: Visera Rhino-Laryngovideoscope Olympus Enf Type V (Jul 24, 2003)
- K032092: Olympus Xcyf-TP3 Cystofiberscope/Nephrofiberscope (Jul 16, 2003)
- K031347: Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 (May 9, 2003)
- K030194: Xues-41 Endoscopic Electrosurgical Unit (Mar 24, 2003)
- K024138: Heat Scissors Generator Set and Heat Scissors Handpiece (Mar 12, 2003)

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