# Olympus Surgical Technologies America

- Location (FDA's records): Southborough, MA
- FDA decisions: 14 (2012–2026): 14 510(k) clearances
- Product codes: KTI (4), GEX (4), KNY (1), ODC (1), FGE (1), KNS (1), EZN (1), GEI (1)
- 510(k) review time since 2016: median 82 days, against 90 for FDA's reviews in the same codes and years (3 of 8 faster)
- Predicates its devices cite: 16 (3 its own); citations of its devices by later devices: 19 (3 its own)
- Recalls linked to its devices: 24 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Spiration, Inc.: 2 (https://510kreport.com/company/spiration)
- Gyrus Acmi, Inc.: 2 (https://510kreport.com/company/gyrus-acmi)
- Circon Corp.: 1 (https://510kreport.com/company/circon)
- Acmi Corporation: 1 (https://510kreport.com/company/acmi)
- Wilson-Cook Medical, Inc.: 1 (https://510kreport.com/company/wilson-cook-medical)
- Cook Ireland, Ltd.: 1 (https://510kreport.com/company/cook-ireland)
- Lumenis, Inc.: 1 (https://510kreport.com/company/lumenis)

## Firms that cite its devices most
- Gyrus Acmi, Inc.: 4 (https://510kreport.com/company/gyrus-acmi)
- Micro-Tech (Nanjing) Co., Ltd.: 1 (https://510kreport.com/company/micro-tech-nanjing)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Patriot Laser, LLC: 1 (https://510kreport.com/company/patriot-laser)
- Leadoptik, Inc.: 1 (https://510kreport.com/company/leadoptik)
- Convergent Laser Technologies: 1 (https://510kreport.com/company/convergent-laser-technologies)
- Serpex Medical, Inc.: 1 (https://510kreport.com/company/serpex-medical)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Its most-cited devices
- K183647: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories) (2019), cited by 6
- K193517: ViziShot 2 FLEX (2020), cited by 2
- K171232: PeriView FLEX (2017), cited by 2
- K163469: ViziShot 2 FLEX (2017), cited by 2
- K242191: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (2024), cited by 2
- K123170: Vari-Pass Variable Length Access Sheath (2013), cited by 1

## Recent decisions
- K262877: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (Sep 16, 2026)
- K261221: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (Jul 24, 2026)
- K242191: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (Aug 23, 2024)
- K212643: POWERSEAL Curved Jaw Sealer and Divider, Double Action (Sep 27, 2021)
- K193517: ViziShot 2 FLEX (Mar 18, 2020)
- K183647: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories) (Aug 9, 2019)
- K190164: CleverLock Guidewire Locking Device and Biopsy Cap (Apr 4, 2019)
- K181193: PeriView FLEX (Jul 3, 2018)

Source page: https://510kreport.com/company/olympus-surgical-technologies-america