DAVIS+GECK REUSABLE TRTOCARS— 510(k) K930254

Substantially Equivalent

Davis & Geck, Inc.

FDA 510(k) clearance K930254 for DAVIS+GECK REUSABLE TRTOCARS, Substantially Equivalent on 1994-03-24. Applicant: Davis & Geck, Inc.. Device class: 2.

Clearance details

Applicant
Davis & Geck, Inc.
Product code
Code GCJ
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Danbury, CT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GCJ

product code GCJ
Death
39
Injury
1,638
Malfunction
28,216
Other
11
Total
29,904

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.