# K031767: Mentor Obtape Trans-Obturator Tape

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Jul 17, 2003 after 38 days
- Product code: OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011251 (2001). 3 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974098: Pubouurethral Sling, ETHICON, Inc. (1998) Summary page 1.
- K013355: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K042851: Mentor Obtape Trans-Obturator Surgical Kit (2004), 8 descendants of its own
- K050148: Mentor Aris Trans-Obturator Tape and Surgical Kit (2005), 7 descendants of its own
- K061445: Surgimesh WN (2007), 5 descendants of its own
- K072974: Surgimesh XB (2008), 3 descendants of its own
- K121562: Altis Single Incision Cling System (2012), 2 descendants of its own

## Indications for use
Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K031767
Methodology: https://510kreport.com/methodology