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510(k) K140558

Device
PROCTIGARD
Applicant
ACCESS PHARMACEUTICALS, INC
510(k) number
K140558
Product code
PHN  
Decision
Substantially Equivalent (SESE)
Decision date
2014-07-16
Date received
2014-03-05
Regulation
510(k) Premarket Notification
Classification name
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Gastroenterology/Urology
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY B DAVIS
Address
1325 Ave. Of The America, 27th Floor New York NY US 10019 10019

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PHN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253923PuraStat3-D Matrix Europe SAS2026-01-07
K242634PuraStat3-D Matrix Europe SAS2025-01-15
K213552PuraStat-RM3-D Matrix, Inc.2022-04-01

Legacy Summary#

summary

FDA Review#

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