510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811568Substantially Equivalent

Cervical Dilator

Gynemetrics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811568 is the FDA 510(k) clearance record for CERVICAL DILATOR, a class I device, cleared for Gynemetrics, Inc. on under FDA product code HDQ (Dilator, Cervical, Fixed Size). FDA records list 4 510(k) clearances for Gynemetrics, Inc., from to . As of , FDA records show no recalls naming K811568.

Clearance record

Decision date
Received
(42 days to decision)
Product code
HDQ Dilator, Cervical, Fixed Size
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Gynemetrics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HDQ

Trailing 12 months

FDA records hold no clearances under product code HDQ in the trailing twelve months.

FDA records show no clearances under product code HDQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HDQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260