510(k) clearances

SchurSign Tissue Marker

Surgmark GmbH · General, Plastic Surgery

K230836Substantially EquivalentTraditionalNEU
Open FDA's page for this record
Third party flag
N
City
Hamburg
Advisory committee description
General, Plastic Surgery
Address 1
Maria-Louisen-Straße 122
Statement or summary
Summary
Product code
NEU
Zip code
22301
Applicant
Surgmark GmbH
Decision date
2024-01-23
Decision code
SESE
Country code
DE
Device name
SchurSign Tissue Marker
Advisory committee
SU
Contact
Christine König
K number
K230836
Date received
2023-03-27
Review advisory committee
SU
Postal code
22301
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Marker, Radiographic, Implantable
Medical specialty description
General, Plastic Surgery
Regulation number
878.4300
Device class
2
Registration number
3018094310, 3021008900, 1835568, 3007366790, 3019807891, 3021179744, 2032338, 3010813819, 3006981798, 3004111573, 3011245468, 3014653199, 3033589330, 2936485, 3015924373, 1625425, 3012644426, 3014090621, 3011162972, 3007738736, 3008236846, 3016678045, 2020394, 3009039068, 1000486410, 3036009309, 3030733800, 3015225571, 3015207155, 3000126629, 3004636440, 3009609358, 3033536844, 1825034, 3014967969, 9617429, 3002907620, 2022435, 3009077524, 1018233 +61 more
FEI number
3018094310, 3021008900, 3019807891, 3003295907, 3021179744, 3010813819, 3006981798, 3007282753, 1000434163, 3004111573, 3011245468, 3014653199, 3033589330, 2936485, 3015924373, 1625425, 3003367650, 3012644426, 3014090621, 3011162972, 3001237677, 3007738736, 3008236846, 3016678045, 2020394, 3002807584, 3009039068, 1000486410, 3036009309, 3030733800, 3003094851, 3015225571, 3015207155, 3000126629, 3004636440, 3009609358, 1000306139, 3033536844, 1825034, 3014967969 +61 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.