ENDOPLUS— 510(k) K941969

Clearance details

Applicant

Wembley Rubber Products (M) Sdn Bhd

Product code

Code BTR

Device class

Class 2

Regulation

21 CFR 868.5730

Advisory panel

Anesthesiology

Date received

1994-04-22

Decision date

1994-06-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sepang Selangor, MY

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Death

92

Injury

1,263

Malfunction

7,475

Other

2

Total

8,832

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 →