JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING— 510(k) K960955
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K960955 for JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING, Substantially Equivalent on 1996-05-22. Applicant: Baxter Healthcare Corp. Device class: 1.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code GBX
- Device class
- Class 1
- Regulation
- 21 CFR 878.4200
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcgaw Park, IL, US
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Adverse events under product code GBX
product code GBX- Death
- 16
- Injury
- 583
- Malfunction
- 3,578
- Other
- 1
- Total
- 4,178
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.