510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974801Substantially Equivalent

Single Channel Balloon Cannula

Conkin Surgical Instruments Ltd., Toronta, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974801 is the FDA 510(k) clearance record for SINGLE CHANNEL BALLOON CANNULA, a class II device, cleared for Conkin Surgical Instruments , Ltd. on under FDA product code HDP (Elevator, Uterine). FDA records list one 510(k) clearance for Conkin Surgical Instruments , Ltd. As of , FDA records show no recalls naming K974801.

Clearance record

Decision date
Received
(199 days to decision)
Product code
HDP Elevator, Uterine
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Conkin Surgical Instruments , Ltd. P.O.Box 6707, Station "A", Toronta, Ontario, CA
510(k) summary
Statement
Third party review
No

Clearances, product code HDP

Trailing 12 months

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

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