LAPAROTOMY SPONGES, STERILE— 510(k) K771395
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K771395 for LAPAROTOMY SPONGES, STERILE, Substantially Equivalent on 1977-08-19. Applicant: Medline Industries, Inc.. Device class: 1.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code GDY
- Device class
- Class 1
- Regulation
- 21 CFR 878.4450
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code GDY
product code GDY- Malfunction
- 764
- Total
- 764
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.