510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K830753Substantially Equivalent

Needle Guide Model 21285A

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

K830753 is the FDA 510(k) clearance record for NEEDLE GUIDE MODEL 21285A, cleared for Hewlett-Packard Co. on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list 246 510(k) clearances for Hewlett-Packard Co., from to . As of , FDA records show no recalls naming K830753.

Clearance record

Decision date
Received
(98 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Hewlett-Packard Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LFL

Trailing 12 months
1 clearance under product code LFL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260