WALLACE Y-CAN— 510(k) K932947

Clearance details

Applicant

Smiths Industries Medical Systems, Inc.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1993-06-17

Decision date

1995-09-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Keene, NH, US

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• K972385 — FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED1998-01-20
• K965017 — REGIONAL ANESTHESIA TRAYS1997-03-14
• K962175 — PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE1997-01-17
• K962931 — SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT1996-10-21
• K963570 — SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)1996-10-18

Death

38

Injury

2,290

Malfunction

25,858

Other

11

Total

28,197

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 →