VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION— 510(k) K971791

Substantially Equivalent

Louisville Laboratories, Inc.

FDA 510(k) clearance K971791 for VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION, Substantially Equivalent on 1997-07-30. Applicant: Louisville Laboratories, Inc..

Clearance details

Applicant: Louisville Laboratories, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 1997-05-15
Decision date: 1997-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.