# American Medical Systems, Inc.

- Location (FDA's records): Minnetonka, MN
- FDA decisions: 83 (1979–2014): 82 510(k) clearances and 1 original PMA approval
- Names in FDA's records: American Medical Systems, Inc. (73); American Medical Systems (10)
- Product codes: OTN (14), OTP (13), FAE (11), PAH (5), GEX (4), KOE (4), FTL (3), OTO (3), EZN (3), MBI (2), HWC (2), FAG (2)
- Predicates its devices cite: 109 (83 its own); citations of its devices by later devices: 133 (83 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Influence, Inc.: 4 (https://510kreport.com/company/influence)
- Laserscope: 2 (https://510kreport.com/company/laserscope)
- Dacomed Corp.: 2 (https://510kreport.com/company/dacomed)
- Mentor Corp.: 2 (https://510kreport.com/company/mentor)
- Acufex Microsurgical, Inc.: 2 (https://510kreport.com/company/acufex-microsurgical)
- ETHICON, Inc.: 2 (https://510kreport.com/company/ethicon)
- Carbon Medical Technologies, Inc.: 1 (https://510kreport.com/company/carbon-medical-technologies)
- Cook Biotech, Inc.: 1 (https://510kreport.com/company/cook-biotech)

## Firms that cite its devices most
- Mpathy Medical Devices, Ltd.: 12 (https://510kreport.com/company/mpathy-medical-devices)
- Mentor Corp.: 5 (https://510kreport.com/company/mentor)
- C.R. Bard, Inc.: 3 (https://510kreport.com/company/cr-bard)
- Cl Medical: 3 (https://510kreport.com/company/cl-medical)
- Caldera Medical, Inc.: 3 (https://510kreport.com/company/caldera-medical)
- Roei Medical Technologies, Ltd.: 2 (https://510kreport.com/company/roei-medical-technologies)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Realton (Suzhou) Medical Technology Co., Ltd.: 2 (https://510kreport.com/company/realton-suzhou-medical-technology)

## Its most-cited devices
- K011251: Sparc Sling System (2001), cited by 13
- K021263: Modification to Sparc Sling System (2002), cited by 10
- K013355: Sparc Sling System (2001), cited by 10
- K023516: Monarc Sling System (2002), cited by 10
- K020663: Modification to Sparc Sling System (2002), cited by 7
- K073703: Ams Miniarc Sling System (2008), cited by 5

## Recent decisions
- K140679: Sureflex Lithotripsy Laser Fibers (Jun 20, 2014)
- K131229: Sparc System and Monarc, Monarc, and Monarc C Systems (Dec 5, 2013)
- K132655: Retroarc Retropubic Sling System (Nov 20, 2013)
- K121805: Ams Large Pore Polyprophlene Mesh (Oct 16, 2012)
- K121641: Miniarc Pro Single-Incision Sling System (Sep 7, 2012)
- K121612: Elevate Prolapse Repair Systems-Apical Needle Passer Sheath Modification (Jul 20, 2012)
- K120870: Greenlight Moxy Fiber Optic (Jun 15, 2012)
- K112842: Ams Elevate PC (Oct 25, 2011)

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