510(k) · Cleared
ClearedEndopath Endoscopic Tissue Fastening System with Coated Vicryl, Models SW210, SW220, SW220,SW230, SW212, SW222 and SW232
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 14, 1999 as substantially equivalent to K980022 (Ethicon Endo-Surgery, Inc., 1998) and 1 other predicate after a 71-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Oct 14, 1999
- Review
- 71 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972679 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 1 generation backK980022 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1998
- This deviceK992612 Endopath Endoscopic Tissue Fastening System with Coated Vicryl…Ethicon Endo-Surgery, Inc. · 1999
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 | K980022 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| 0 (this device) | K992612 | Endopath Endoscopic Tissue Fastening System with Coated Vicryl, Models SW210… | Ethicon Endo-Surgery, Inc. | 1999 | — |
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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K980022 | Endopath Endoscopic Tissue Fastening System (Etfs)Summary page 1…prietary Name is ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL®. Ethicon Endo-Surgery’s ENDOPATH® Endoscopic Tissue Fastening System . (ETFS)-K980022; Ethicon Endo-Surgery’s ENDOPATH® Endoscopic Tissuc Fastening System (ETFS)-K972679. The ENDOPATH® Endoscopic Tissue Fastening… | 1998 |
| * | K972679 | Endopath Endoscopic Tissue Fastening System (Etfs)Summary page 1…RYL®. Ethicon Endo-Surgery’s ENDOPATH® Endoscopic Tissue Fastening System . (ETFS)-K980022; Ethicon Endo-Surgery’s ENDOPATH® Endoscopic Tissuc Fastening System (ETFS)-K972679. The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® is a single patient use reloadable instrument that… | 1997 |
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 2 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K980022.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches.
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/K992612 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992612: Endopath Endoscopic Tissue Fastening System with Coated Vicryl, Models SW210, SW220, SW220,SW230, SW212, SW222 and SW232.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992612
Report an extraction error
Are you the manufacturer?
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