KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536— 510(k) K072216

Name: FDA 510(k) clearance K072216
Creator: U.S. Food and Drug Administration
Published: 2007-11-09

Substantially Equivalent

Kapp Surgical Instrument, Inc.

FDA 510(k) clearance K072216 for KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536, Substantially Equivalent on 2007-11-09. Applicant: Kapp Surgical Instrument, Inc.. Device class: 2.

Clearance details

Applicant: Kapp Surgical Instrument, Inc.
Product code: Code NEU
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2007-08-09
Decision date: 2007-11-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Warrensville, OH, US

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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.