DOW CORNING/W RIGHT WOUND DRAINAGE SYS— 510(k) K800014

Clearance details

Applicant

Dow Corning Corp. Healthcare Industries Materials

Product code

Code GCY

Device class

Class 1

Regulation

21 CFR 878.4680

Advisory panel

General, Plastic Surgery

Date received

1980-01-04

Decision date

1980-01-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEM1997-10-01
• K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE1997-06-03
• K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-5001996-12-12
• K960099 — PENROSE DRAIN MODELS 6001 - 60071996-03-11
• K950754 — MACRO SUCTION TUBE MODEL NO 100611995-04-25

• K853186 — SILASTIC INFLATABLE BONE PLUG H.P.1985-09-24
• K844637 — WHITESIDE ACRYLIC CEMENT SPACER SLEEVE1985-06-19
• K850255 — DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET1985-05-01
• K843995 — TF-II HIP PROSTHESIS1985-04-23
• K842559 — WHITESIDE ORTHOLOC TOTAL HIP FEMORAL1984-12-20

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 →