510(k) · Cleared
ClearedPolyglycolic Acid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trading Consultants and Distributors Intl., Inc. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Feb 9, 2000 as substantially equivalent to K972566 (Davis & Geck, Inc., 1997) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Feb 9, 2000
- Review
- 77 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K900198 (1990). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900198 | Dexon II Absorbable Surgical Suture, U.S.P. | American Cyanamid Co. | 1990 | — |
| −1 | K972566 | Dexon Violet | Davis & Geck, Inc. | 1997 | — |
| 0 (this device) | K994001 | Polyglycolic Acid | Trading Consultants and Distributors Intl., Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 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 GAM? 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 GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 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 |
|---|---|---|---|
| * | K972566 | Dexon VioletSummary page 1…fication Name: Absorbable Poly (glycolide/L-lactide) Surgical Suture (Per 21CFR878.4493) C. Predicate Device: DEXON II® Polyglycolic Acid Surgical Suture, Davis & Geck (K972566) Ethicon Absorbable Poly (L-lactide/glycolide) Surgical Suture, Undyed. (K964345) D. Device Description: POLYGLYCOLIC ACID is a… | 1997 |
| * | K964345 | Ethicon Absorbable Poly (L-Lactide/Glycolide) Surgical Suture, UndyedSummary page 1…8.4493) C. Predicate Device: DEXON II® Polyglycolic Acid Surgical Suture, Davis & Geck (K972566) Ethicon Absorbable Poly (L-lactide/glycolide) Surgical Suture, Undyed. (K964345) D. Device Description: POLYGLYCOLIC ACID is a synthetic absorbable sterile surgical suture composed of a synthetic polyglycolic… | 1996 |
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 10 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 6 other devices also cite its predicate K972566.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
POLYGLYCOLIC ACID 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/K994001 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994001: Polyglycolic Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994001
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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