# Mentor Corp.

- Location (FDA's records): Goleta, CA
- FDA decisions: 67 (1977–2013): 65 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Mentor Corp. (63); Mentor Corporation (4)
- Product codes: LCJ (9), FAD (8), FAE (5), OTN (4), MRD (2), EXJ (2), LJE (2), LFL (2), QPB (2), GDS (2), EZD (2), GZJ (2)
- Predicates its devices cite: 35 (12 its own); citations of its devices by later devices: 51 (12 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- American Medical Systems, Inc.: 5 (https://510kreport.com/company/american-medical-systems)
- Deschutes Medical Products, Inc.: 3 (https://510kreport.com/company/deschutes-medical-products)
- Bioteque America, Inc.: 2 (https://510kreport.com/company/bioteque-america)
- Morwel Corp.: 1 (https://510kreport.com/company/morwel)
- Valleylab, Inc.: 1 (https://510kreport.com/company/valleylab)
- Gynecare, A Div. of Ethicon, Inc.: 1 (https://510kreport.com/company/gynecare-a-div-of-ethicon)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)
- Ximed Medical Systems: 1 (https://510kreport.com/company/ximed-medical-systems)

## Firms that cite its devices most
- Mentor Worldwide, LLC: 5 (https://510kreport.com/company/mentor-worldwide)
- Coloplast A/S: 3 (https://510kreport.com/company/coloplast-a-s)
- Sound Surgical Technologies, LLC: 3 (https://510kreport.com/company/sound-surgical-technologies)
- Coloplast Manufacturing Us, LLC: 2 (https://510kreport.com/company/coloplast-manufacturing-us)
- Hollister, Inc.: 2 (https://510kreport.com/company/hollister)
- Sofradim Production: 2 (https://510kreport.com/company/sofradim-production)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- American Medical Systems, Inc.: 2 (https://510kreport.com/company/american-medical-systems)

## Its most-cited devices
- K980483: Mentor Suspend Sling (1998), cited by 7
- K003873: Mentor Self-Cath Closed System (2001), cited by 6
- K970471: Mentor Ultrasound Assisted Tissue Removal System (TRS) (1997), cited by 4
- K050148: Mentor Aris Trans-Obturator Tape and Surgical Kit (2005), cited by 4
- K130813: Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue Expanders (2013), cited by 4
- K003784: Mentor Self-Cath Plus (2001), cited by 3

## Recent decisions
- K130813: Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue Expanders (Apr 11, 2013)
- P030053: Memorygel Silicone Gel -Filled Breast Implants (Nov 17, 2006)
- K062421: Mentor Resterilizable Gel Breast Implant Sizer (Oct 10, 2006)
- K053414: Mentor Novasilk Mesh (Dec 27, 2005)
- K053296: Mentor Aris Suprapubic Surgical Kit (Dec 15, 2005)
- K052440: Mentor Self-Cath Hydrogel Intermittent Catheter (Oct 11, 2005)
- K050008: Mentor Self-Cath Hydrogel Intermittent Catheter (Jun 3, 2005)
- K050148: Mentor Aris Trans-Obturator Tape and Surgical Kit (Mar 9, 2005)

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