JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339— 510(k) K933728

Name: FDA 510(k) clearance K933728
Creator: U.S. Food and Drug Administration
Published: 1994-02-23

Substantially Equivalent

J. Jamner Surgical Instruments, Inc.

FDA 510(k) clearance K933728 for JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339, Substantially Equivalent on 1994-02-23. Applicant: J. Jamner Surgical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: J. Jamner Surgical Instruments, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1993-08-02
Decision date: 1994-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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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.