510(k) clearances

Restrata

Acera Surgical, Inc. · Unknown

K261245Substantially EquivalentTraditionalQSZ
Open FDA's page for this record
Third party flag
N
City
St. Louis
Advisory committee description
Unknown
Address 1
1650 Des Peres Rd.
Address 2
Suite 120
Statement or summary
Summary
Product code
QSZ
Zip code
63131
Applicant
Acera Surgical, Inc.
Decision date
2026-10-16
Decision code
SESE
Country code
US
Device name
Restrata
Contact
Tamas Kovacs
K number
K261245
State
MO
Date received
2026-04-16
Review advisory committee
SU
Postal code
63131
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Absorbable Synthetic Wound Dressing
Medical specialty description
Unknown
Device class
U
Registration number
1526534, 1424263, 3027386220, 3012429393, 3020659113, 2183319, 3007093114, 3003477135, 3014527904, 2245304, 3006017180, 3002808271, 3007886187, 3013542522, 3012366156, 3025431504, 3007735241, 3012448339, 3038550164, 3007710611
FEI number
1526534, 3027386220, 3012429393, 3020659113, 2183319, 3007093114, 3003015552, 3003477135, 3014527904, 2245304, 3006017180, 3002808271, 3007886187, 3013542522, 3012366156, 3025431504, 3007735241, 3012448339, 3038550164, 3007710611
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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.