510(k) clearances

PuraStat GI

3-D Matrix, Inc. · General, Plastic Surgery

K261503Substantially EquivalentTraditionalQAU
Open FDA's page for this record
Third party flag
N
City
Newton
Advisory committee description
General, Plastic Surgery
Address 1
1234 Chestnut St., Suite 205
Statement or summary
Summary
Product code
QAU
Zip code
02464
Applicant
3-D Matrix, Inc.
Decision date
2026-08-03
Decision code
SESE
Country code
US
Device name
PuraStat GI
Advisory committee
SU
Contact
Alan MISKEWICZ
K number
K261503
State
MA
Date received
2026-05-06
Review advisory committee
SU
Postal code
02464
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Hemostatic Device For Endoscopic Gastrointestinal Use
Medical specialty description
General, Plastic Surgery
Regulation number
878.4456
Device class
2
Registration number
3013557562, 3012263097, 3015528146, 3007162658, 3013155768, 1450662, 1036836, 3004681519, 1058584, 3005689226, 3007225047, 3005465238, 3020614064, 1037905, 3010481555, 3030733800, 3014579161, 3002807408
FEI number
3013557562, 3012263097, 3015528146, 1000219637, 3007162658, 3013155768, 1450662, 1036836, 3010481555, 3005689226, 3007225047, 3005465238, 3003870583, 1037905, 3020614064, 3030733800, 3014579161, 3002807408
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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.