SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK— 510(k) K935391

Clearance details

Applicant

3M Health Care, Sarns

Product code

Code GFA

Device class

Class 1

Regulation

21 CFR 878.4820

Advisory panel

General, Plastic Surgery

Date received

1993-11-08

Decision date

1994-02-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ann Arbor, MI, US

• K971978 — GRAFT HARVESTING SAWBLADES1997-06-18
• K954483 — STRYKER SAGITTAL SAW ATTACHMENT1996-01-30
• K955229 — WRIGHT MEDICAL TECHNOLOGY SAWBLADES1996-01-18
• K953012 — DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS1995-07-12
• K950403 — SURGICAL SAW BLADES1995-02-21

• K960916 — SAMS 8000 CARDIOPLEGIA MONITOR1996-06-04
• K953901 — SARNS 800 ROLLER PUMP1996-04-19
• K950739 — 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM1995-11-17
• K941653 — SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION1994-08-24
• K941654 — SARNS FILTERED VENOUS RESERVIOR MODIFICATION1994-07-26

Death

2

Injury

140

Malfunction

2,337

Total

2,479

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 →