510(k) · Cleared
ClearedNeatstitch Neatclose Suturing Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neat Stitch, Ltd. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Jan 12, 2007 as substantially equivalent to K011105 (Qrc Consulting, 2001) and 2 other predicates after a 58-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Jan 12, 2007
- Review
- 58 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K900198 (1990). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK900198 Dexon II Absorbable Surgical Suture, U.S.P.American Cyanamid Co. · 1990
- 2 generations backK972566 Dexon VioletDavis & Geck, Inc. · 1997
- 1 generation backK040282 Atramat and Sorb-Fast Polyglycolic AcidInternacional Farmaceutica, S.A. DE C.V. · 2004
- This deviceK063462 Neatstitch Neatclose Suturing DeviceNeat Stitch, Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900198 | Dexon II Absorbable Surgical Suture, U.S.P. | American Cyanamid Co. | 1990 | — |
| −2 | K972566 | Dexon Violet | Davis & Geck, Inc. | 1997 | — |
| −1 | K040282 | Atramat and Sorb-Fast Polyglycolic Acid | Internacional Farmaceutica, S.A. DE C.V. | 2004 | — |
| 0 (this device) | K063462 | Neatstitch Neatclose Suturing Device | Neat Stitch, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
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 GAM? 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 GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011105 | Suturtek Fastclose Fascia Closure Device | 2001 |
| * | K981531 | Suture Placement Device and AccessoriesSummary page 1…3. Identification of Predicate or Legally marketed Device FASTCLOSE Suturing Device (KOl 1I105) LSI Solutions Suture Placement Device (K98153 1) ATRAMAT and SuperSorb Polyglycolic Acid Surgical Sutures (K040282). 4. Device description The… | 1998 |
| * | K040282 | Atramat and Sorb-Fast Polyglycolic AcidSummary page 1…LOSE Suturing Device (KOl 1I105) LSI Solutions Suture Placement Device (K98153 1) ATRAMAT and SuperSorb Polyglycolic Acid Surgical Sutures (K040282). 4. Device description The NeatClose Suturing Device has three major component: 1) a reusable… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 3 other devices also cite its predicate K011105.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
The NeatStitch NeatClose suturing device is intended for the approximation and/or ligation of soft tissues in laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063462 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063462: Neatstitch Neatclose Suturing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063462
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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