510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210098Substantially Equivalent

PuraStat-GI

3-D Matrix, Inc., Newton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210098 is the FDA 510(k) clearance record for PuraStat-GI, a class II device, cleared for 3-D Matrix, Inc. on under FDA product code QAU (Hemostatic Device For Endoscopic Gastrointestinal Use). FDA's definition for product code QAU reads: "Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to...". FDA records list 9 510(k) clearances for 3-D Matrix, Inc., from to . As of , FDA records show no recalls naming K210098.

Clearance record

Decision date
Received
(162 days to decision)
Product code
QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Regulation
21 CFR 878.4456
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
3-D Matrix, Inc. 1234 Chestnut St., Suite 205, Newton MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QAU

Trailing 12 months
3 clearances under product code QAU in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QAU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260