GRAFTSITE— 510(k) K173110
Substantially EquivalentSummit Medical , Ltd.
FDA 510(k) clearance K173110 for GRAFTSITE, Substantially Equivalent on 2018-05-18. Applicant: Summit Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Summit Medical , Ltd.
- Product code
- Code BSP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bourton On The Water, GB
Recent devices under product code BSP
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view all- K170388 — ANCHORMAN Tibial Ligament Fixation Device
- K024097 — SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14
- K022477 — SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET
- K022489 — SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
Adverse events under product code BSP
product code BSP- 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.