510(k) · Cleared
ClearedAuto Suture*Endostitch* II** Suture Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Apr 25, 1998 after a 261-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 22 later devices descend from it.
- Decided
- Apr 25, 1998
- Review
- 261 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
22 later devices descend from it, 3 citing it directly.
- This deviceK972911 Auto Suture*Endostitch* II** Suture ApplierUnited States Surgical, A Division of Tyco Healthc · 1998
- Descendant · cites it directly · 11 of its ownK061386 Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK062307 Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006
- Descendant · cites it directly · 8 of its ownK081853 Overstitch Endoscopic Suture SystemApollo Endosurgery, Inc. · 2008
- Descendant · 2 generations on · 7 of its ownK171886 OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc. · 2017
- Descendant · 2 generations on · 7 of its ownK100572 Versaclose, Model VC-200-01Anulex Technologies, Inc. · 2010
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K061386Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006 · cites it directly11descendants
- K062307Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006 · 2 generations on9descendants
- K081853Overstitch Endoscopic Suture SystemApollo Endosurgery, Inc. · 2008 · cites it directly8descendants
- K171886OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc. · 2017 · 2 generations on7descendants
- K100572Versaclose, Model VC-200-01Anulex Technologies, Inc. · 2010 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972911 | Auto Suture*Endostitch* II** Suture Applier | United States Surgical, A Division of Tyco Healthc | 1998 | — |
| +1 | K061386 | Anchor Band Suturing System, Model SR-AB | Anulex Technologies, Inc. | 2006 | — |
| +2 | K062307 | Xclose Tissue Repair System, Model SRS | Anulex Technologies, Inc. | 2006 | — |
| +1 | K081853 | Overstitch Endoscopic Suture System | Apollo Endosurgery, Inc. | 2008 | — |
| +2 | K171886 | OverStitch SX Endoscopic Suturing System (ESS) | Apollo Endosurgery, Inc. | 2017 | — |
| +2 | K100572 | Versaclose, Model VC-200-01 | Anulex Technologies, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K961173 | FDA’s K961173 is 1.2MM Reusable Neuroview Endoscope Our OCR of the scanned summary read K961173, FDA’s number for 1.2MM Reusable Neuroview Endoscope (Neuro Navigational Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Modified Endoscopic Suturing device”. Kept off the family tree. Summary page 1…orwalk, CT 06856 Victor M. Clavelli April 24, 1998 Manual Surgical Instrument for General Use Suture Passer Not Yet Determined Modified Endoscopic Suturing** device K961173 ' The Auto Suture* SurgiStitch** suture passer is designed to pass either one or both needles of a double armed suture through t… | 1996 |
What descends from it? (22)
See all 223 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K061386 (Anulex Technologies, Inc., 2006) has gone furthest, with 11 descendants of its own.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
The Auto Suture* SurgiStitch** suture passer is indicated for the placement of
interrupted sutures for soft tissue approximation in surgical procedures such as
cardiovascular and gastrointestinal surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972911 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972911: Auto Suture*Endostitch* II** Suture Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972911
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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