# Hydrocision, Inc.

- Location (FDA's records): Hopkonton, MA
- FDA decisions: 12 (1998–2025): 12 510(k) clearances
- Product codes: HRX (9), FQH (3)
- 510(k) review time since 2016: median 68 days, against 107 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 19 (9 its own); citations of its devices by later devices: 18 (9 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Valleylab, Inc.: 3 (https://510kreport.com/company/valleylab)
- Stryker Instruments: 1 (https://510kreport.com/company/stryker-instruments)
- Xomed, Inc.: 1 (https://510kreport.com/company/xomed)
- Andreas Pein Medizintechnik GmbH: 1 (https://510kreport.com/company/andreas-pein-medizintechnik)
- The Anspach Effort, Inc.: 1 (https://510kreport.com/company/anspach-effort)
- Kirwan Surgical Products, Inc.: 1 (https://510kreport.com/company/kirwan-surgical-products)
- Arthrocare Corp.: 1 (https://510kreport.com/company/arthrocare)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)

## Firms that cite its devices most
- Mitek Worldwide: 4 (https://510kreport.com/company/mitek-worldwide)
- Andreas Pein Medizintechnik GmbH: 2 (https://510kreport.com/company/andreas-pein-medizintechnik)
- Smith & Nephew Wound Management: 1 (https://510kreport.com/company/smith-nephew-wound-management)
- Corespine Technologies, LLC: 1 (https://510kreport.com/company/corespine-technologies)
- Ouroboros Medical: 1 (https://510kreport.com/company/ouroboros-medical)

## Its most-cited devices
- K982266: Hydrocision Arthrojet System (1998), cited by 4
- K041233: Arthrojet XT (2004), cited by 4
- K991383: Hydrocision Debdridement System (2000), cited by 2
- K020688: Hydrocision Arthojet System with Cautery and Turboburr (2002), cited by 2
- K002764: Hydrocision Arthrojet System with Cautery and Burr (2000), cited by 2
- K011612: Modification to Hydrocision Debridement System (2001), cited by 2

## Recent decisions
- K241990: SpineSite Endoscope System (Jul 30, 2025)
- K200729: HydroCision SpineJet System (Apr 16, 2020)
- K190804: HydroCision TenJet Device (Jun 5, 2019)
- K041233: Arthrojet XT (Jul 28, 2004)
- K032529: Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310 (Sep 16, 2003)
- K021813: Hydrocision General Surgery Fluidjet System (May 9, 2003)
- K020688: Hydrocision Arthojet System with Cautery and Turboburr (Apr 3, 2002)
- K011612: Modification to Hydrocision Debridement System (Jun 22, 2001)

Source page: https://510kreport.com/company/hydrocision