510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K971588Substantially Equivalent

Evi Sutured-Clip Applier

Elective Vascular Intervention Inc. (Evi), Walnut Creek CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971588 is the FDA 510(k) clearance record for EVI SUTURED-CLIP APPLIER, a class II device, cleared for Elective Vascular Intervention Inc. (Evi) on under FDA product code FZP (Clip, Implantable). FDA records list one 510(k) clearance for Elective Vascular Intervention Inc. (Evi). As of , FDA records show no recalls naming K971588.

Clearance record

Decision date
Received
(176 days to decision)
Product code
FZP Clip, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Elective Vascular Intervention Inc. (Evi) 2108 Blackwood Dr., Walnut Creek CA
510(k) summary
Summary
Third party review
No

Clearances, product code FZP

Trailing 12 months
5 clearances under product code FZP in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FZP, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260