REDYROB-CLOSED WOUND DRAINAGE SYSTEM— 510(k) K972703

Clearance details

Applicant

B.Braun Medical, Inc.

Product code

Code GCY

Device class

Class 1

Regulation

21 CFR 878.4680

Advisory panel

General, Plastic Surgery

Date received

1997-07-18

Decision date

1997-10-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bethlehem, PA, US

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Malfunction

786

Other

1

Total

787

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 →