SILASTIC BRAND G7-2090A— 510(k) K760700

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

1976-09-22

Decision date

1976-11-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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• K853186 — SILASTIC INFLATABLE BONE PLUG H.P.1985-09-24
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• 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 →