510(k) · Cleared
ClearedPlain/Chromic Catgut
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trading Consultants and Distributors Intl., Inc. · GAL Suture, Absorbable, Natural
Cleared on Feb 4, 2000 as substantially equivalent to K930589 (Davis & Geck, Inc., 1993) after a 72-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Feb 4, 2000
- Review
- 72 days
- Class
- Class II
- Product code
- GAL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930589 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK930589 Plain, Mild Chromic and Chromic Surgical Gut SuturDavis & Geck, Inc. · 1993
- This deviceK994002 Plain/Chromic CatgutTrading Consultants and Distributors Intl., Inc. · 2000
- Descendant · cites it directly · 0 of its ownK072930 Demetech Absorbable Surgical Suture Plain & Chromic GutDemetech Corp. · 2008
- Descendant · cites it directly · 0 of its ownK021043 Grams Absorbable Surgical Gut Suture Plain & ChromicGramsmed, LLC · 2002
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930589 | Plain, Mild Chromic and Chromic Surgical Gut Sutur | Davis & Geck, Inc. | 1993 | — |
| 0 (this device) | K994002 | Plain/Chromic Catgut | Trading Consultants and Distributors Intl., Inc. | 2000 | — |
| +1 | K072930 | Demetech Absorbable Surgical Suture Plain & Chromic Gut | Demetech Corp. | 2008 | — |
| +1 | K021043 | Grams Absorbable Surgical Gut Suture Plain & Chromic | Gramsmed, LLC | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 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 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? (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 |
|---|---|---|---|
| * | K930589 | Plain, Mild Chromic and Chromic Surgical Gut SuturSummary page 1…Chromic c. Classification Name: Absorbable surgical gut Suture. (Per 21CFR878.4830) C. Predicate Device: Plain and Chromic Absorbable Surgical Sutures of Davis & Geck (K930589) SOFTGUT® Plain and Chromic Absorbable Surgical Suture (Davis & Geck) D. Device Description: CATGUT, Plain and Chromic, is an ab… | 1993 |
| * | — | SOFTGUT® Plain and Chromic Absorbable Surgical Suture (Davis & Geck) Named without a submission number |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K072930 (Demetech Corp., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GAL devicesGAL Suture, Absorbable, Natural: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
CATGUT is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
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/K994002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994002: Plain/Chromic Catgut.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994002
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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