SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070— 510(k) K033317

Substantially Equivalent

Opus Medical, Inc.

FDA 510(k) clearance K033317 for SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070, Substantially Equivalent on 2003-12-30. Applicant: Opus Medical, Inc..

Clearance details

Applicant: Opus Medical, Inc.
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 2003-10-15
Decision date: 2003-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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Adverse events under product code OCW

product code OCW

Death: 6
Injury: 443
Malfunction: 1,023
Other: 2
Total: 1,474

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.