OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK— 510(k) K091838

Substantially Equivalent

Obp Medical

FDA 510(k) clearance K091838 for OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK, Substantially Equivalent on 2009-12-04. Applicant: Obp Medical.

Clearance details

Applicant: Obp Medical
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2009-06-22
Decision date: 2009-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawerence, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.