510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K110766Substantially Equivalent

Kolplux System

Kolplast Ci Ltda, Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110766 is the FDA 510(k) clearance record for KOLPLUX SYSTEM, a class II device, cleared for Kolplast CI Ltda on under FDA product code HIB (Speculum, Vaginal, Nonmetal). FDA records list one 510(k) clearance for Kolplast CI Ltda. As of , FDA records show no recalls naming K110766.

Clearance record

Decision date
Received
(181 days to decision)
Product code
HIB Speculum, Vaginal, Nonmetal
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Kolplast CI Ltda 1468 Harwell Ave., Crofton MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIB

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