USSC POLYPROPLENE SUTURE— 510(k) K954808

Clearance details

Applicant

United States Surgical, A Division of Tyco Healthc

Product code

Code GAW

Device class

Class 2

Regulation

21 CFR 878.5010

Advisory panel

General, Plastic Surgery

Date received

1995-10-19

Decision date

1996-02-27

Decision

Substantially Equivalent for Some Indications

Clearance type

Traditional

Location

Norwalk, CT, 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

• K071406 — AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER2007-11-21
• K071920 — AUTOSUTURE ABSORBABLE TACK AND APPLICATOR2007-09-28
• K061288 — AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER2006-11-02
• K062850 — AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS2006-10-23
• K062326 — AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE2006-09-01

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-1179-2023 — Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DAClass II·Ongoing·Covidien, LP·20221202

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954808.