510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864623Substantially Equivalent

Obstetrical/gynecological Custom Surgical Kit

Xanmed Corp., Central Islip NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864623 is the FDA 510(k) clearance record for OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT, a class II device, cleared for Xanmed Corp. on under FDA product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic). FDA records list 9 510(k) clearances for Xanmed Corp., from to . As of , FDA records show no recalls naming K864623.

Clearance record

Decision date
Received
(50 days to decision)
Product code
KNA Instrument, Manual, Specialized Obstetric-Gynecologic
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Xanmed Corp. 85v. Hoffman Ln., Central Islip NY
Third party review
No

Clearances, product code KNA

Trailing 12 months

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

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