DISPOSABLE BAG DECANTER— 510(k) K934179
Substantially EquivalentByron Medical
FDA 510(k) clearance K934179 for DISPOSABLE BAG DECANTER, Substantially Equivalent on 1994-05-23. Applicant: Byron Medical. Device class: 2.
Clearance details
- Applicant
- Byron Medical
- Product code
- Code KPE
- Device class
- Class 2
- Regulation
- 21 CFR 880.5025
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
Recent devices under product code KPE
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- K001803 — ACCELERATOR RECIPROCATING CANNULA
- 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 KPE
product code KPE- Malfunction
- 1,000
- Other
- 1
- Total
- 1,001
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.