510(k) · Cleared
ClearedDemetech Absorbable Surgical Suture Plain & Chromic Gut
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Demetech Corp. · GAL Suture, Absorbable, Natural
Cleared on Apr 30, 2008 as substantially equivalent to K991223 (Aesculap, Inc., 1999) and 2 other predicates after a 197-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Apr 30, 2008
- Review
- 197 days
- Class
- Class II
- Product code
- GAL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K930589 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK930589 Plain, Mild Chromic and Chromic Surgical Gut SuturDavis & Geck, Inc. · 1993
- 1 generation backK994002 Plain/Chromic CatgutTrading Consultants and Distributors Intl., Inc. · 2000
- This deviceK072930 Demetech Absorbable Surgical Suture Plain & Chromic GutDemetech Corp. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930589 | Plain, Mild Chromic and Chromic Surgical Gut Sutur | Davis & Geck, Inc. | 1993 | — |
| −1 | K994002 | Plain/Chromic Catgut | Trading Consultants and Distributors Intl., Inc. | 2000 | — |
| 0 (this device) | K072930 | Demetech Absorbable Surgical Suture Plain & Chromic Gut | Demetech Corp. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K991223 | Absorbable Surgical Gut Suture, Plain and Chronic and Softcat Absorbable Surgical Gut…Summary page 1…substantially equivalent to these predicate devices: o AESCULAP Absorbable Surgical Gut Suture, Plain & Chromic & Softcat Gut Suture, 510K Number K991223, AESCULAP, San Diego California. o T. Cad International, Plain/Chromic Catgut Suture, Trading Consultants& Distributors… | 1999 |
| * | K994002 | Plain/Chromic CatgutSummary page 1…223, AESCULAP, San Diego California. o T. Cad International, Plain/Chromic Catgut Suture, Trading Consultants& Distributors International Inc. 510K Number K994002, Chicago IL. o CP Medical, Plain and Chromic Absorbable Surgical Gut Suture, 510K Number K001299, CP Medical Portl… | 2000 |
| * | K001299 | Plain and Chromic Gut Absorbable Surgical Sutures UspSummary page 1…ants& Distributors International Inc. 510K Number K994002, Chicago IL. o CP Medical, Plain and Chromic Absorbable Surgical Gut Suture, 510K Number K001299, CP Medical Portland Oregon. F. Device Description: Demetech Surgical gut suture (Plain and Chromic) is an absorbab… | 2000 |
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 15 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K991223.
How does its category compare?
All GAL devicesGAL Suture, Absorbable, Natural: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Demetech Absorbable Surgical Gut Suture (Plain and Chromic) 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 as stated in the FDA summary.
https://510kreport.com/device/K072930 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072930: Demetech Absorbable Surgical Suture Plain & Chromic Gut.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072930
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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