510(k) Report

510(k) · Cleared

Cleared

Gyne Ideas Minitape RP Device

K023898510(k) TraditionalCleared Jun 18, 2003208-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gyne Ideas, Ltd. · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

Cleared on Jun 18, 2003 as substantially equivalent to K974098 (ETHICON, Inc., 1998) and 5 other predicates after a 208-day review. Its family tree reaches back 4 generations to 2001. 4 later devices descend from it.

Decided
Jun 18, 2003
Review
208 days
Class
Class II
Product code
PAH
Recalls
None
Predicates
7

Its longest line of descent runs back 4 generations to K011251 (2001). 12 ancestors in all, the oldest K945377 (1994). 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 4 other ancestors1998: 2 other ancestors2001: 1 other ancestor1994: 1 other ancestor2008: 2 descendants cleared2009: 2 descendants cleared×2: 2 generations cleared close together, K011251 (2001), K013355 (2001) ×2: 2 generations cleared close together, K020663 (2002), K021263 (2002) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants K021263 · Modification to Sparc Sling System · American Medical Systems, Inc. · 2002K020663 · Modification to Sparc Sling System · American Medical Systems, Inc. · 2002K013355 · Sparc Sling System · American Medical Systems, Inc. · 2001K011251 · Sparc Sling System · American Medical Systems, Inc. · 20010
  1. Root · 4 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  2. 3 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  3. 2 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  4. 1 generation backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  5. This deviceK023898 Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd. · 2003
  6. Descendant · cites it directly · 2 of its ownK073646 Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2008
  7. Descendant · 2 generations on · 1 of its ownK091180 Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009
  8. Descendant · cites it directly · 1 of its ownK073647 Minitape Extra Urethral SlingMpathy Medical Devices, Ltd. · 2008
  9. Descendant · 2 generations on · 0 of its ownK092203 Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009

Most influential descendants

Showing 4 of 4 · See all
  • K073646Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2008 · cites it directly2descendants
  • K091180Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009 · 2 generations on1descendant
  • K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd. · 2008 · cites it directly1descendant
  • K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K011251Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−3K013355Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−2K020663Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−1K021263Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
0 (this device)K023898Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd.2003—
+1K073646Minitape Urethral SlingMpathy Medical Devices, Ltd.2008—
+2K091180Minitape Urethral SlingMpathy Medical Devices, Ltd.2009—
+1K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd.2008—
+2K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199820
200110
200240

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200920
FIG. 1 — Lineage of K023898, 2001–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PAH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new PAH device

  1. #1 K242473 Altis Single Incision Sling System (519650)…score 10.9 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K974098Pubouurethral Sling
Summary page 1
…otland Science Park Glasgow, UK. Louis J. Mazzarese (U.S. Agent for Gyneldeas, Ltd.) November 20, 2002 Polymeric Surgical Mesh Urethral Sling Gyne Ideas Minitape RP™ K974098 — Tension Free Vaginal Tape (TVT) System (Ethicon, Inc.) K010553 - Biosling (Injetx, Inc.) K020007 - SAFYRE Sling (Corniche, LL…
ETHICON, Inc.1998—
Kept off the family treeK010553FDA’s K010553 is Precision Xtra Blood Glucose Test Strip with Truemeasure Technology
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
…for Gyneldeas, Ltd.) November 20, 2002 Polymeric Surgical Mesh Urethral Sling Gyne Ideas Minitape RP™ K974098 — Tension Free Vaginal Tape (TVT) System (Ethicon, Inc.) K010553 - Biosling (Injetx, Inc.) K020007 - SAFYRE Sling (Corniche, LLC) K020110 - Surgical Mesh (Boston Scientific) K020652 - T-Sling…
Abbott Laboratories2001—
*K020007Safyre Sling System
Summary page 1
…002 Polymeric Surgical Mesh Urethral Sling Gyne Ideas Minitape RP™ K974098 — Tension Free Vaginal Tape (TVT) System (Ethicon, Inc.) K010553 - Biosling (Injetx, Inc.) K020007 - SAFYRE Sling (Corniche, LLC) K020110 - Surgical Mesh (Boston Scientific) K020652 - T-Sling (Herniamesh USA, Inc.) K020705 —…
Promedon2002—
*K020110Modification to Trelex Mesh Surgical Mesh
Summary page 1
…ing Gyne Ideas Minitape RP™ K974098 — Tension Free Vaginal Tape (TVT) System (Ethicon, Inc.) K010553 - Biosling (Injetx, Inc.) K020007 - SAFYRE Sling (Corniche, LLC) K020110 - Surgical Mesh (Boston Scientific) K020652 - T-Sling (Herniamesh USA, Inc.) K020705 — SiiS#1 Tissue Suspension System (T.A.G.…
Boston Scientific2002—
*K020652Herniamesh T-Sling
Summary page 1
…n Free Vaginal Tape (TVT) System (Ethicon, Inc.) K010553 - Biosling (Injetx, Inc.) K020007 - SAFYRE Sling (Corniche, LLC) K020110 - Surgical Mesh (Boston Scientific) K020652 - T-Sling (Herniamesh USA, Inc.) K020705 — SiiS#1 Tissue Suspension System (T.A.G. Medical Products, Ltd.) K021263 - SPARC Slin…
Herniamesh2002—
*K020705Siis#1 Tissue Suspension System
Summary page 1
…Inc.) K010553 - Biosling (Injetx, Inc.) K020007 - SAFYRE Sling (Corniche, LLC) K020110 - Surgical Mesh (Boston Scientific) K020652 - T-Sling (Herniamesh USA, Inc.) K020705 — SiiS#1 Tissue Suspension System (T.A.G. Medical Products, Ltd.) K021263 - SPARC Sling System (American Medical Systems) The d…
Tag Medical Products2002—
*K021263Modification to Sparc Sling System
Summary page 1
…, LLC) K020110 - Surgical Mesh (Boston Scientific) K020652 - T-Sling (Herniamesh USA, Inc.) K020705 — SiiS#1 Tissue Suspension System (T.A.G. Medical Products, Ltd.) K021263 - SPARC Sling System (American Medical Systems) The device consists of a polypropylene sling with integral serrated anchoring a…
American Medical Systems, Inc.2002—

Also cleared against K974098: 11 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073646Minitape Urethral SlingMpathy Medical Devices, Ltd.20082
K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd.20081

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 5 months on median.
  • None of the 12 ancestors has a recall.
  • Of its descendants, K073646 (Mpathy Medical Devices, Ltd., 2008) has gone furthest, with 2 descendants of its own.
  • 11 other devices also cite its predicate K974098.

How does its category compare?

All PAH devices

PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · PAH

1in 2024

2007: 22008: 32009: 22010: 12011: 12012: 42020: 12023: 12024: 1
2007high 4 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PAH

128in 2012

2008: 61 days median2012: 128 days median
2007high 128 (2012) · low 61 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PAH

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PAH

242in 2025

2010: 12011: 72012: 1292013: 2,3862014: 3382015: 2752016: 6972017: 1272018: 1742019: 2982020: 1712021: 3182022: 1592023: 1542024: 2872025: 242
2007high 2,386 (2013) · low 0 (2007)2025

MAUDE reports naming product code PAH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
200836100
20092—00
20101—01
20111—07
201241280129
20130—02,386
20140—0338
20150—1275
20160—0697
20170—0127
20180—0174
20190—0298
20201—0171
20210—0318
20220—0159
20231—0154
20241—0287
20250—0242
20260—0—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K974098

11 other devices cite the same predicate.

  • K173019GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence…ETHICON, Inc. · 2018
  • K100485Gynecare TVT Exact Continence SystemETHICON, Inc. · 2010
  • K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009
  • K052175I-Stop Mid-Urethral Sling, Models IS-1000, IS-2000, IS-3000, IS-4000Uroplasty, Inc. · 2005
  • K041176Uretex to Trans-Obturator Urethral Support SystemSofradim Production · 2004
  • K031767Mentor Obtape Trans-Obturator TapeMentor Corp. · 2003

Recent decisions in PAH

The PAH category page

  • K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic…Coloplast Corp. · 2024
  • K221874Altis Single Incision Sling SystemColoplast A/S · 2023
  • K191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackCaldera Medical, Inc. · 2020
  • K121562Altis Single Incision Cling SystemColoplast A/S · 2012
  • K123179Ajust Helical Adjustable Single-Incision SlingC.R. Bard, Inc. · 2012

https://510kreport.com/device/K023898 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023898: Gyne Ideas Minitape RP Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023898

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026