510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103695Substantially Equivalent

Prepex System

Circ Medtech, Chalotte NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103695 is the FDA 510(k) clearance record for PREPEX SYSTEM, a class II device, cleared for Circ Medtech on under FDA product code HFX (Clamp, Circumcision). FDA records list one 510(k) clearance for Circ Medtech. As of , FDA records show no recalls naming K103695.

Clearance record

Decision date
Received
(389 days to decision)
Product code
HFX Clamp, Circumcision
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Circ Medtech 1914 J.N. Pease Pl., Chalotte NC
510(k) summary
Summary PDF
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