510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190813Substantially Equivalent

CrossBay Cervical Dilator Catheter System

Crossbay Medical, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190813 is the FDA 510(k) clearance record for CrossBay Cervical Dilator Catheter System, a class II device, cleared for Crossbay Medical on under FDA product code PON (Catheter, Balloon, Dilation Of Cervical Canal). FDA's definition for product code PON reads: "Mechanical dilation and softening of the cervix". FDA records list 6 510(k) clearances for Crossbay Medical, from to . As of , FDA records show no recalls naming K190813.

Clearance record

Decision date
Received
(147 days to decision)
Product code
PON Catheter, Balloon, Dilation Of Cervical Canal
Regulation
21 CFR 884.4260
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Crossbay Medical 13240 Evening Creek Dr., Suite 304, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PON

Trailing 12 months

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

FDA records show no clearances under product code PON in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PON, 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