# K023898: Gyne Ideas Minitape RP Device

- Pathway: 510(k) (Traditional)
- Applicant: Gyne Ideas, Ltd.
- Decided: Jun 18, 2003 after 208 days
- Product code: PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling)
- 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: 4 generations back to K011251 (2001). 12 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 17 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.
- K020007: Safyre Sling System, Promedon (2002) Summary page 1.
- K020110: Modification to Trelex Mesh Surgical Mesh, Boston Scientific (2002) Summary page 1.
- K020652: Herniamesh T-Sling, Herniamesh (2002) Summary page 1.
- K020705: Siis#1 Tissue Suspension System, Tag Medical Products (2002) Summary page 1.
- K021263: Modification to Sparc Sling System, American Medical Systems, Inc. (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K010553: Precision Xtra Blood Glucose Test Strip with Truemeasure Technology, Abbott Laboratories (2001). Our OCR of the scanned summary read K010553, FDA’s number for Precision Xtra Blood Glucose Test Strip with Truemeasure… (Abbott Laboratories). Its FDA name has none of the distinctive words the summary uses for the device it names, “Biosling”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K073646: Minitape Urethral Sling (2008), 2 descendants of its own
- K091180: Minitape Urethral Sling (2009), 1 descendant of its own
- K073647: Minitape Extra Urethral Sling (2008), 1 descendant of its own
- K092203: Omnisure Urethral Sling, Model OTK52 (2009), 0 descendants of its own

## Indications for use
The subject device is intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K023898
Methodology: https://510kreport.com/methodology