510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K973853Substantially Equivalent

Kolplast Vaginal Speculum

Kolplast Comercial E Industrial Ltda, Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973853 is the FDA 510(k) clearance record for KOLPLAST VAGINAL SPECULUM, a class II device, cleared for Kolplast Comercial E Industrial Ltda on under FDA product code HIB (Speculum, Vaginal, Nonmetal). FDA records list one 510(k) clearance for Kolplast Comercial E Industrial Ltda. As of , FDA records show no recalls naming K973853.

Clearance record

Decision date
Received
(72 days to decision)
Product code
HIB Speculum, Vaginal, Nonmetal
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Kolplast Comercial E Industrial Ltda P.O. Box 4341, Crofton MD
510(k) summary
Statement
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