URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0— 510(k) K982626

Name: FDA 510(k) clearance K982626
Creator: U.S. Food and Drug Administration
Published: 1998-08-20

Substantially Equivalent

Medworks Corp.

FDA 510(k) clearance K982626 for URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0, Substantially Equivalent on 1998-08-20. Applicant: Medworks Corp.. Device class: 2.

Clearance details

Applicant: Medworks Corp.
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1998-07-28
Decision date: 1998-08-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Pawtucket, RI, US

Download summary PDF View on FDA.gov ↗

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K982630 — MEDWORKS VISUALIZATION INSEMINATION CATHETER1999-01-14
K982628 — MEDWORKS INSEMINATION CATHETER1998-08-21

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.