510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K071225Substantially Equivalent

Innovasa Stat*seal Topical Hemostat

Innovasa, Inc., Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K071225 is the FDA 510(k) clearance record for INNOVASA STAT*SEAL TOPICAL HEMOSTAT, a class II device, cleared for Innovasa, Inc. on under FDA product code DXC (Clamp, Vascular). FDA records list one 510(k) clearance for Innovasa, Inc. As of , FDA records show no recalls naming K071225.

Clearance record

Decision date
Received
(121 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Innovasa, Inc. 16625 Redmond Way, Redmond WA
510(k) summary
Statement
Third party review
No

Clearances, product code DXC

Trailing 12 months
6 clearances under product code DXC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20261
August 20260
September 20260
October 20260