Prometheus ChitoGauze XR PRO— 510(k) K153582
Substantially EquivalentHem Con Medical Technologies, Inc.
FDA 510(k) clearance K153582 for Prometheus ChitoGauze XR PRO, Substantially Equivalent on 2016-05-25. Applicant: Hem Con Medical Technologies, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Hem Con Medical Technologies, Inc.
- Product code
- Code QSY
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, OR, US
Recent devices under product code QSY
view allMore clearances from Hem Con Medical Technologies, Inc.
view all- K150916 — HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
- K103641 — GUARDACARE
- K111163 — CHITOGAUZE FUSION
- K102546 — CHITOGAUZE
- K092357 — CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2
Adverse events under product code QSY
product code QSY- Death
- 5
- Other
- 1
- Total
- 6
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.