510(k) clearances

PuraStat-RM

3-D Matrix, Inc. · Unknown

K261504Substantially EquivalentTraditionalPHN
Open FDA's page for this record
Third party flag
N
City
Newton
Advisory committee description
Unknown
Address 1
1234 Chestnut St., Suite 205
Statement or summary
Summary
Product code
PHN
Zip code
02464
Applicant
3-D Matrix, Inc.
Decision date
2026-08-03
Decision code
SESE
Country code
US
Device name
PuraStat-RM
Contact
Alan Miskewicz
K number
K261504
State
MA
Date received
2026-05-06
Review advisory committee
GU
Postal code
02464
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Medical specialty description
Unknown
Device class
U
Registration number
3016611551, 3007162658, 3015528146, 3012263097, 3004681519, 3005689226, 3005465238, 3010481555, 3002807408
FEI number
3016611551, 3007162658, 3015528146, 3012263097, 3005689226, 3005465238, 3003870583, 3010481555, 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.