510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950889Substantially Equivalent

Adel 5000

Stryker Corp., Kalamazoo MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950889 is the FDA 510(k) clearance record for ADEL 5000, a class II device, cleared for Stryker Corp. on under FDA product code HDD (Table, Obstetrical, Ac-Powered (And Accessories)). FDA records list 568 510(k) clearances for Stryker Corp., from to . As of , FDA records show 4 recalls naming K950889.

Clearance record

Decision date
Received
(230 days to decision)
Product code
HDD Table, Obstetrical, Ac-Powered (And Accessories)
Regulation
21 CFR 884.4900
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Stryker Corp. 420 Alcott St., Kalamazoo MI
510(k) summary
Statement
Third party review
No

Clearances, product code HDD

Trailing 12 months

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

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