510(k) · Cleared
ClearedOverstitch Endoscopic Suture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apollo Endosurgery, Inc. · OCW Endoscopic Tissue Approximation Device
Cleared on Aug 18, 2008 as substantially equivalent to K061770 (Ethicon Endo-Surgery, Inc., 2006) and 2 other predicates after a 49-day review. Its family tree reaches back 2 generations to 1997. 8 later devices descend from it.
- Decided
- Aug 18, 2008
- Review
- 49 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K972679 (1997). 5 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 1 generation backK061770 Ethicon Endo Surgery Endoscopic Suturing SystemEthicon Endo-Surgery, Inc. · 2006
- This deviceK081853 Overstitch Endoscopic Suture SystemApollo Endosurgery, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK171886 OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK181141 OverStitch Endoscopic Suturing System and AccessoriesApollo Endosurgery · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK211309 endomina systemEndo Tools Therapeutics S.A. · 2021
- Descendant · 3 generations on · 1 of its ownK210266 OverStitch Sx Endoscopic Suturing SystemApollo Endosurgery, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK252400 Endomina EZFuse systemEndo Tools Therapeutics S.A. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K171886OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc. · 2017 · cites it directly7descendants
- K181141OverStitch Endoscopic Suturing System and AccessoriesApollo Endosurgery · 2018 · 2 generations on3descendants
- K211309endomina systemEndo Tools Therapeutics S.A. · 2021 · 2 generations on1descendant
- K210266OverStitch Sx Endoscopic Suturing SystemApollo Endosurgery, Inc. · 2021 · 3 generations on1descendant
- K252400Endomina EZFuse systemEndo Tools Therapeutics S.A. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972679 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −1 | K061770 | Ethicon Endo Surgery Endoscopic Suturing System | Ethicon Endo-Surgery, Inc. | 2006 | — |
| 0 (this device) | K081853 | Overstitch Endoscopic Suture System | Apollo Endosurgery, Inc. | 2008 | — |
| +1 | K171886 | OverStitch SX Endoscopic Suturing System (ESS) | Apollo Endosurgery, Inc. | 2017 | — |
| +2 | K181141 | OverStitch Endoscopic Suturing System and Accessories | Apollo Endosurgery | 2018 | 2 |
| +2 | K211309 | endomina system | Endo Tools Therapeutics S.A. | 2021 | — |
| +3 | K210266 | OverStitch Sx Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2021 | — |
| +3 | K252400 | Endomina EZFuse system | Endo Tools Therapeutics S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 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 OCW? 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 OCW device
- #1 K252400 Endomina EZFuse systemscore 12.1 · 5 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 |
|---|---|---|---|
| * | K061770 | Ethicon Endo Surgery Endoscopic Suturing SystemSummary page 1…llo Endosurgery OverStitch Endoscopic Suture System is intended for endoscopic placement of suture(s) and approximation of soft tissue. Predicate Devices K061770 Endoscopic Suturing System (ESS) Ethicon Endo Surgery K003956 EndoCinch Suturin… | 2006 |
| * | K003956 | Bard Endocinch Suturing System # 000452; 000454; 000595Summary page 1…re(s) and approximation of soft tissue. Predicate Devices K061770 Endoscopic Suturing System (ESS) Ethicon Endo Surgery K003956 EndoCinch Suturing System Davol / Bard K972911 Auto Suture-Endo Stitch… | 2001 |
| * | K972911 | Auto Suture*Endostitch* II** Suture ApplierSummary page 1…scopic Suturing System (ESS) Ethicon Endo Surgery K003956 EndoCinch Suturing System Davol / Bard K972911 Auto Suture-Endo Stitch Tyco Healthcare Device Description The Apollo Endosurgery OverSt… | 1998 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171886 | OverStitch SX Endoscopic Suturing System (ESS) | 2017 | 7 |
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 11 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K171886 (Apollo Endosurgery, Inc., 2017) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K061770.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The Apollo Endosurgery OverStitch Endoscopic Suture System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081853 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081853: Overstitch Endoscopic Suture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081853
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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