510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K071405Substantially Equivalent

Probe Holder System

Intuitive Surgical, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071405 is the FDA 510(k) clearance record for PROBE HOLDER SYSTEM, a class II device, cleared for Intuitive Surgical, Inc. on under FDA product code LKF (Cannula, Manipulator/Injector, Uterine). FDA records list 196 510(k) clearances for Intuitive Surgical, Inc., from to . As of , FDA records show no recalls naming K071405.

Clearance record

Decision date
Received
(141 days to decision)
Product code
LKF Cannula, Manipulator/Injector, Uterine
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Intuitive Surgical, Inc. 950 Kifer Rd., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LKF

Trailing 12 months
1 clearance under product code LKF in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LKF, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260