510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895026Substantially Equivalent

Hp Model M1318a Transvaginal Ultrasound Transducer

Hewlett-Packard Co., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895026 is the FDA 510(k) clearance record for HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER, a class II device, cleared for Hewlett-Packard Co. on under FDA product code HGL (Transducer, Ultrasonic, Obstetric). FDA records list 246 510(k) clearances for Hewlett-Packard Co., from to . As of , FDA records show no recalls naming K895026.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HGL Transducer, Ultrasonic, Obstetric
Regulation
21 CFR 884.2960
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hewlett-Packard Co. 3000 Minuteman Rd., Andover MA
Third party review
No

Clearances, product code HGL

Trailing 12 months

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

FDA records show no clearances under product code HGL in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HGL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260