510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002915Substantially Equivalent

Flexible Occlusion System

Applied Medical, Rancho Santa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002915 is the FDA 510(k) clearance record for FLEXIBLE OCCLUSION SYSTEM, a class II device, cleared for Applied Medical on under FDA product code DXC (Clamp, Vascular). FDA records list 14 510(k) clearances for Applied Medical, from to . As of , FDA records show no recalls naming K002915.

Clearance record

Decision date
Received
(112 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Applied Medical 22872 Avenida Empresa, Rancho Santa CA
510(k) summary
Summary
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