3 MM SELEC-TIP LAPAROSCOPIC SCISSORS— 510(k) K980758

Name: FDA 510(k) clearance K980758
Creator: U.S. Food and Drug Administration
Published: 1998-03-27

Substantially Equivalent

Microline Pentax, Inc.

FDA 510(k) clearance K980758 for 3 MM SELEC-TIP LAPAROSCOPIC SCISSORS, Substantially Equivalent on 1998-03-27. Applicant: Microline Pentax, Inc.. Device class: 2.

Clearance details

Applicant: Microline Pentax, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1998-02-27
Decision date: 1998-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley, MA, US

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K981389 — DISPOSABLE RE-NEW FORCEPS1998-05-29
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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.