510(k) · Cleared
ClearedInscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, LLC · OCW Endoscopic Tissue Approximation Device
Cleared on Aug 15, 2007 as substantially equivalent to K003956 (C.R. Bard, Inc., 2001) and 3 other predicates after a 211-day review. Its family tree reaches back 4 generations to 1997. 4 later devices descend from it.
- Decided
- Aug 15, 2007
- Review
- 211 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K972679 (1997). 8 ancestors in all, the oldest K934738 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 3 generations backK980022 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1998
- 2 generations backK994290 Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000
- 1 generation backK062875 Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2007
- This deviceK070151 Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and…Ethicon Endo-Surgery, LLC · 2007
- Descendant · cites it directly · 3 of its ownK073671 Plicator GSX Suturing System, Plicator GSX, Plicator Instrument…Ndo Surgical, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK082044 Ace Stapler, Model F0031Barosense, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK110829 Ace Stapler and CartridgeBarosense, Inc. · 2011
- Descendant · 4 generations on · 0 of its ownK120147 Ace Stapler and CartridgeBarosense, Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K073671Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture…Ndo Surgical, Inc. · 2008 · cites it directly3descendants
- K082044Ace Stapler, Model F0031Barosense, Inc. · 2010 · 2 generations on2descendants
- K110829Ace Stapler and CartridgeBarosense, Inc. · 2011 · 3 generations on1descendant
- K120147Ace Stapler and CartridgeBarosense, Inc. · 2012 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972679 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −3 | K980022 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −2 | K994290 | Bard Endoscopic Suturing System | C.R. Bard, Inc. | 2000 | — |
| −1 | K062875 | Endogastric Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | 2007 | — |
| 0 (this device) | K070151 | Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting… | Ethicon Endo-Surgery, LLC | 2007 | — |
| +1 | K073671 | Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX… | Ndo Surgical, Inc. | 2008 | — |
| +2 | K082044 | Ace Stapler, Model F0031 | Barosense, Inc. | 2010 | — |
| +3 | K110829 | Ace Stapler and Cartridge | Barosense, Inc. | 2011 | — |
| +4 | K120147 | Ace Stapler and Cartridge | Barosense, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 12.0 · 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? (4)
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 |
|---|---|---|---|
| * | K003956 | Bard Endocinch Suturing System # 000452; 000454; 000595Summary page 1…Classification Name: Endoscope and Accessories [2I1CFR 876.1500 (OCW, MXW, GAW)] Predicate Device Bard® EndoCinchTM Suturing System (K003956) LSI Solutions Flexible Suture Placement Device and Acc (KOI 101 6) Ethicon End… | 2001 |
| * | K011016 | Lsi Solutions Flexible Suture Placement Device and Accessories Product | 2001 |
| * | K061770 | Ethicon Endo Surgery Endoscopic Suturing SystemSummary page 1…6) LSI Solutions Flexible Suture Placement Device and Acc (KOI 101 6) Ethicon Endo-Surgery® Endoscopic Suturing System (K061770) EndoGastric Solutions StomaphyXTm endoluminal fastener and delivery system… | 2006 |
| * | K062875 | Endogastric Stomaphyx Device and Accessories Cleared while this submission was under review Summary page 1…y® Endoscopic Suturing System (K061770) EndoGastric Solutions StomaphyXTm endoluminal fastener and delivery system (K062875) Device Description The InScopeTm Tissue Apposition System is a sterile, single patient use disposable suture system for approxim… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073671 | Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture… | 2008 | 3 |
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 10 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K073671 (Ndo Surgical, Inc., 2008) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K003956.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Tissue Apposition System (TAS) is indicated for endoscopic placement of suture(s) and approximation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070151: Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070151
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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