# K904906: Sharpoint Polypropylene Nonabsorb Surg Sutures Usp

- Pathway: 510(k) (Traditional)
- Applicant: Chathamborough Research Group, Inc.
- Decided: Dec 24, 1990 after 60 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K131224: Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill Polypropylene Knotless Tissue-Closure (2013), 2 descendants of its own
- K233355: Cypris eXact Suturing System (2024), 0 descendants of its own
- K211178: DURAMESH Mesh Suture (2022), 0 descendants of its own

## Recalls of this device
- May 20, 2016 · Class II · Z-2042-2016: Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.

Source page: https://510kreport.com/device/K904906
Methodology: https://510kreport.com/methodology