510(k) · Cleared
ClearedAbsorbable Synthetic Suture with Needle Attachment (Pga Braided)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Pudong Jinhuan Medical Products Co., Ltd. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Sep 4, 2008 as substantially equivalent to K984374 (Samyang Corp., 1999) and 1 other predicate after a 202-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 4, 2008
- Review
- 202 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K951352 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK951352 Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid SutureDavis & Geck, Inc. · 1995
- This deviceK080412 Absorbable Synthetic Suture with Needle Attachment (Pga Braided)Shanghai Pudong Jinhuan Medical Products Co., Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951352 | Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid Suture | Davis & Geck, Inc. | 1995 | — |
| 0 (this device) | K080412 | Absorbable Synthetic Suture with Needle Attachment (Pga Braided) | Shanghai Pudong Jinhuan Medical Products Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K984374 | SurgisorbSummary page 1…Shanghai Pudong Jinhuan Medical Products Co., Ltd. Product Code: GAM K984374 Samyang Corporation Predicate Device: K951352 DAVIS & GECK, INC. Intended Use: Absorbabl… | 1999 |
| * | K951352 | Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid SutureSummary page 1…GAM K984374 Samyang Corporation Predicate Device: K951352 DAVIS & GECK, INC. Intended Use: Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is indicated for use in gen… | 1995 |
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?
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K984374.
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. 2008, this device’s year, is highlighted.
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?
Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is indicated for use in general soft tissue approximation including ophthalmic surgery. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is not indicated for cardiovascular and neurological tissue approximation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080412: Absorbable Synthetic Suture with Needle Attachment (Pga Braided).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080412
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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