P-S SURGICAL DRAIN— 510(k) K801442

Clearance details

Applicant

Pudenz-Schulte Medical Research Corp.

Product code

Code GCY

Device class

Class 1

Regulation

21 CFR 878.4680

Advisory panel

General, Plastic Surgery

Date received

1980-06-20

Decision date

1980-07-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

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• K950754 — MACRO SUCTION TUBE MODEL NO 100611995-04-25

• K960055 — MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 89321996-09-30
• K954409 — PS MEDICAL IPI VASCULAR ACCESS CATHETER1995-12-18
• K951258 — PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT1995-09-18
• K934167 — IPI DUAL LUMEN PORT1994-07-14
• K934796 — IPI LOW PROFILE IMPORT1994-07-14

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 →