510(k) · Cleared
Recalled · Class II · 2023Surgical Gut Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GAL Suture, Absorbable, Natural
Cleared on Jan 29, 2015 as substantially equivalent to K885018 (United States Surgical, A Division of Tyco Healthc, 1989) after a 133-day review. Its family tree reaches back 1 generation to 1989. It has been recalled 3 times.
- Decided
- Jan 29, 2015
- Review
- 133 days
- Class
- Class II
- Product code
- GAL
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K885018 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK885018 Absorbable Surgical Gut Suture*United States Surgical, A Division of Tyco Healthc · 1989
- This deviceK142656 Surgical Gut SutureCovidien · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885018 | Absorbable Surgical Gut Suture* | United States Surgical, A Division of Tyco Healthc | 1989 | — |
| 0 (this device) | K142656 | Surgical Gut Suture | Covidien | 2015 | — |
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 GAL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K885018 | Absorbable Surgical Gut Suture*Summary page 4…suture is a Class II device LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCY IS CLAIMED: Surgical Gut Suture (K885018) K142656 page 2of 2 REASON FOR 510… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2023 | Class II | Z-1388-2023 | Process control | Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the… |
| Mar 1, 2023 | Class II | Z-1390-2023 | Process control | Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the… |
| Mar 1, 2023 | Class II | Z-1389-2023 | Process control | Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K885018.
How does its category compare?
All GAL devicesGAL Suture, Absorbable, Natural: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GAL
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · GAL
Too few GAL 510(k)s in any year since 2007 to give a median.
Recalls per year · GAL
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAL
117in 2025
MAUDE reports naming product code GAL, 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 | 0 | — | 0 | 13 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 25 |
| 2010 | 0 | — | 0 | 57 |
| 2011 | 0 | — | 0 | 36 |
| 2012 | 0 | — | 0 | 27 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 0 | — | 0 | 157 |
| 2015 | 1 | — | 0 | 137 |
| 2016 | 0 | — | 0 | 87 |
| 2017 | 0 | — | 0 | 133 |
| 2018 | 0 | — | 0 | 246 |
| 2019 | 0 | — | 1 | 229 |
| 2020 | 0 | — | 0 | 109 |
| 2021 | 0 | — | 0 | 120 |
| 2022 | 0 | — | 0 | 130 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 161 |
| 2025 | 0 | — | 0 | 117 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Plain, Chromic and Mild Chromic gut absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in microsurgery, cardiovascular or neurological surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142656: Surgical Gut Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142656
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