ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY— 510(k) K932988

Substantially Equivalent

Smith & Nephew Richards, Inc.

FDA 510(k) clearance K932988 for ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY, Substantially Equivalent on 1993-07-26. Applicant: Smith & Nephew Richards, Inc..

Clearance details

Applicant
Smith & Nephew Richards, Inc.
Product code
Code EOB
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bartlett, TN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EOB

product code EOB
Malfunction
6,143
Total
6,143

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.