# K003015: Ssc's PCL Monofilament Sas, Violet, Coated, Model TBD

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Specialties Corp
- Decided: Dec 15, 2000 after 79 days
- Product code: GAN (Suture, Absorbable, Synthetic)
- Device class: 2
- Regulation: 21 CFR 878.4830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K051093: Osteopore PCL Scaffold (2006), 2 descendants of its own
- K020882: Sharpoint Ultraplug Extended Wear Plug (2002), 1 descendant of its own
- K251959: TnR Cranial Implant (2026), 0 descendants of its own
- K123633: TRS Cranial Bone Void Filler (TRS C-BVF) (2013), 0 descendants of its own
- K053333: Eaglevision Gellanserts, Model Ref 0040 (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K003015
Methodology: https://510kreport.com/methodology