510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K010867Substantially Equivalent

Kilejian Circumcisor

Iris Surgical, LLC, St.Augustine FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010867 is the FDA 510(k) clearance record for KILEJIAN CIRCUMCISOR, a class II device, cleared for Iris Surgical, LLC on under FDA product code HFX (Clamp, Circumcision). FDA records list one 510(k) clearance for Iris Surgical, LLC. As of , FDA records show no recalls naming K010867.

Clearance record

Decision date
Received
(42 days to decision)
Product code
HFX Clamp, Circumcision
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Iris Surgical, LLC 446 Arricola Ave., St.Augustine FL
510(k) summary
Summary
Third party review
No

Clearances, product code HFX

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