AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH— 510(k) K922123
Substantially EquivalentUnited States Surgical, A Division of Tyco Healthc
FDA 510(k) clearance K922123 for AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH, Substantially Equivalent on 1993-02-01. Applicant: United States Surgical, A Division of Tyco Healthc.
Clearance details
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Product code
- Code GCI
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norwalk, CT, US
Adverse events under product code GCI
product code GCI- Malfunction
- 635
- Total
- 635
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.