# Rusch Intl.

- Location (FDA's records): Jeffrey, NH
- FDA decisions: 43 (1995–2003): 43 510(k) clearances
- Product codes: BTR (7), JOH (5), KNT (4), EZL (4), KOD (2), NYT (2), ESW (2), FEN (2), CAE (1), FAP (1), CAZ (1), BSP (1)
- Predicates its devices cite: 32 (7 its own); citations of its devices by later devices: 48 (7 its own)
- Recalls linked to its devices: 90 (60 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Rusch, Inc.: 5 (https://510kreport.com/company/rusch)
- Sheridan Catheter Corp.: 5 (https://510kreport.com/company/sheridan-catheter)
- Smiths Industries Medical Systems, Inc.: 2 (https://510kreport.com/company/smiths-industries-medical-systems)
- Cook Urological, Inc.: 2 (https://510kreport.com/company/cook-urological)
- Bivona Medical Technologies: 2 (https://510kreport.com/company/bivona-medical-technologies)
- Williams Airway Intubator: 1 (https://510kreport.com/company/williams-airway-intubator)
- Mentor Corp.: 1 (https://510kreport.com/company/mentor)
- Unoplast A/S: 1 (https://510kreport.com/company/unoplast-a-s)

## Firms that cite its devices most
- Teleflexmedical, Inc.: 8 (https://510kreport.com/company/teleflexmedical)
- Alveolus, Inc.: 6 (https://510kreport.com/company/alveolus)
- Well Lead Medical Instruments: 4 (https://510kreport.com/company/well-lead-medical-instruments)
- Boston Scientific Corp: 3 (https://510kreport.com/company/boston-scientific)
- Teleflex, Inc.: 3 (https://510kreport.com/company/teleflex)
- Convatec Limited: 2 (https://510kreport.com/company/convatec)
- Hangzhou Bever Medical Devices Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-bever-medical-devices)
- Mentor Medical Limited: 1 (https://510kreport.com/company/mentor-medical)

## Its most-cited devices
- K000070: Flocath (2000), cited by 6
- K993786: Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy (2000), cited by 6
- K961837: Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy (1996), cited by 5
- K013266: Rusch Polyflex Stent Kit (2001), cited by 4
- K030559: Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery System (2003), cited by 4
- K951046: Rusch Endotest Cuff Pressure Monitor (1995), cited by 3

## Recent decisions
- K033023: Intermittent Urethral Catheters (Dec 23, 2003)
- K030559: Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery System (Jun 30, 2003)
- K023666: Rusch Guided Cholangiography Catheter (Jun 17, 2003)
- K023918: Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless (Mar 28, 2003)
- K023964: Rusch Microlaryngeal Tube (Dec 23, 2002)
- K021540: Rusch Edgar Tube (Aug 1, 2002)
- K021764: Rusch Tracheofix Set, Cuffed and Uncuffed (Jul 23, 2002)
- K020714: Rusch Floneil; Flocath Introgel (Jul 1, 2002)

Source page: https://510kreport.com/company/rusch-intl