SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP— 510(k) K904906

Clearance details

Applicant

Chathamborough Research Group, Inc.

Product code

Code GAW

Device class

Class 2

Regulation

21 CFR 878.5010

Advisory panel

General, Plastic Surgery

Date received

1990-10-25

Decision date

1990-12-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Pittsboro, NC, US

• K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device2026-03-27
• K233355 — Cypris eXact Suturing System2024-01-12
• K230746 — Non absorbable Surgical Polypropylene Suture2023-09-14
• K221280 — Vesseal2022-12-09
• K211178 — DURAMESH Mesh Suture2022-09-02

• K915676 — SPLATTER SHIELD1992-09-11
• K902309 — PARKER MICROPUMP MODEL 21001990-08-17
• K863034 — SHARPOINT STAINLESS STEEL SUTURE1986-09-30

Death

66

Injury

1,616

Malfunction

10,428

Total

12,110

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2042-2016 — Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558NClass II·Terminated·SSC- Surgical Specialties Corporation·20160520

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904906.