BYRON WORD BARTHOLIAN GLAND CATHETER— 510(k) K861877
Substantially EquivalentByron Medical
FDA 510(k) clearance K861877 for BYRON WORD BARTHOLIAN GLAND CATHETER, Substantially Equivalent on 1986-05-30. Applicant: Byron Medical. Device class: 1.
Clearance details
- Applicant
- Byron Medical
- Product code
- Code GBA
- 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
- Tucson, AZ, US
Recent devices under product code GBA
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- K981215 — PSI-TEC LIPOSUCTION ASPIRATOR
- K981172 — LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES
- K980738 — PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION
Adverse events under product code GBA
product code GBA- Death
- 2
- Total
- 2
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.