510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862310Substantially Equivalent

Cabot Medical Variable Flow Insufflator

Cabot Medical Corp., Langhorne PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862310 is the FDA 510(k) clearance record for CABOT MEDICAL VARIABLE FLOW INSUFFLATOR, a class II device, cleared for Cabot Medical Corp. on under FDA product code HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)). FDA records list 38 510(k) clearances for Cabot Medical Corp., from to . As of , FDA records show no recalls naming K862310.

Clearance record

Decision date
Received
(56 days to decision)
Product code
HES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Regulation
21 CFR 884.1300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Cabot Medical Corp. 2021 Cabot Blvd. W., Langhorne PA
Third party review
No

Clearances, product code HES

Trailing 12 months

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

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