510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963505Substantially Equivalent

Tenet Mlti-Positioning Surgical Stirrup System

Tenet Medical Engineering, Calgary, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963505 is the FDA 510(k) clearance record for TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM, a class II device, cleared for Tenet Medical Engineering on under FDA product code HHP (Table, Obstetrical, Manual (And Accessories)). FDA records list 3 510(k) clearances for Tenet Medical Engineering, from to . As of , FDA records show no recalls naming K963505.

Clearance record

Decision date
Received
(164 days to decision)
Product code
HHP Table, Obstetrical, Manual (And Accessories)
Regulation
21 CFR 884.4900
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Tenet Medical Engineering 3553 31st St., NW, Calgary, CA
510(k) summary
Statement
Third party review
No

Clearances, product code HHP

Trailing 12 months

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

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