MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES— 510(k) K936247

Substantially Equivalent

Medicon Instruments, Inc.

FDA 510(k) clearance K936247 for MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES, Substantially Equivalent on 1994-05-19. Applicant: Medicon Instruments, Inc.. Device class: 2.

Clearance details

Applicant
Medicon Instruments, Inc.
Product code
Code DRC
Device class
Class 2
Regulation
21 CFR 870.1390
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Washington, DC, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DRC

product code DRC
Death
28
Injury
412
Total
440

Source: openFDA MAUDE database, through . 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.