510(k) · Cleared
ClearedSsc's PCL Monofilament Sas, Violet, Coated, Model TBD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Specialties Corp · GAN Suture, Absorbable, Synthetic
Cleared on Dec 15, 2000 after a 79-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 15, 2000
- Review
- 79 days
- Class
- Class II
- Product code
- GAN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK003015 Ssc's PCL Monofilament Sas, Violet, Coated, Model TBDSurgical Specialties Corp · 2000
- Descendant · cites it directly · 2 of its ownK051093 Osteopore PCL ScaffoldOsteopore, Inc. · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK020882 Sharpoint Ultraplug Extended Wear PlugSurgical Specialties Corp · 2002
- Descendant · 2 generations on · 0 of its ownK251959 TnR Cranial ImplantT&R BIOFAB CO., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK123633 TRS Cranial Bone Void Filler (TRS C-BVF)Tissue Regeneration Systems, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK053333 Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K051093Osteopore PCL ScaffoldOsteopore, Inc. · 2006 · cites it directly2descendants
- K020882Sharpoint Ultraplug Extended Wear PlugSurgical Specialties Corp · 2002 · cites it directly1descendant
- K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd. · 2026 · 2 generations on0descendants
- K123633TRS Cranial Bone Void Filler (TRS C-BVF)Tissue Regeneration Systems, Inc. · 2013 · 2 generations on0descendants
- K053333Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003015 | Ssc's PCL Monofilament Sas, Violet, Coated, Model TBD | Surgical Specialties Corp | 2000 | — |
| +1 | K051093 | Osteopore PCL Scaffold | Osteopore, Inc. | 2006 | 1 |
| +1 | K020882 | Sharpoint Ultraplug Extended Wear Plug | Surgical Specialties Corp | 2002 | — |
| +2 | K251959 | TnR Cranial Implant | T&R BIOFAB CO., Ltd. | 2026 | — |
| +2 | K123633 | TRS Cranial Bone Void Filler (TRS C-BVF) | Tissue Regeneration Systems, Inc. | 2013 | — |
| +2 | K053333 | Eaglevision Gellanserts, Model Ref 0040 | Eagle Vision, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
| 2013 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAN? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K051093 (Osteopore, Inc., 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GAN devicesGAN Suture, Absorbable, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAN
FDA has decided no GAN device since 2007.
Median 510(k) review, days · GAN
Too few GAN 510(k)s in any year since 2007 to give a median.
Recalls per year · GAN
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAN
410in 2025
MAUDE reports naming product code GAN, 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 | 86 |
| 2008 | 0 | — | 0 | 124 |
| 2009 | 0 | — | 0 | 67 |
| 2010 | 0 | — | 0 | 23 |
| 2011 | 0 | — | 0 | 62 |
| 2012 | 0 | — | 0 | 157 |
| 2013 | 0 | — | 0 | 103 |
| 2014 | 0 | — | 0 | 92 |
| 2015 | 0 | — | 0 | 76 |
| 2016 | 0 | — | 0 | 63 |
| 2017 | 0 | — | 0 | 67 |
| 2018 | 0 | — | 0 | 400 |
| 2019 | 0 | — | 0 | 434 |
| 2020 | 0 | — | 0 | 278 |
| 2021 | 0 | — | 0 | 301 |
| 2022 | 0 | — | 0 | 327 |
| 2023 | 0 | — | 0 | 343 |
| 2024 | 0 | — | 1 | 450 |
| 2025 | 0 | — | 0 | 410 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K003015 · printed Nov 3, 2026
Cite this page
510(k) Report. “K003015: Ssc's PCL Monofilament Sas, Violet, Coated, Model TBD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003015
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026