510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896637Substantially Equivalent

Access(tm), Software Release 4.11P

Diasonics, Inc., S. San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896637 is the FDA 510(k) clearance record for ACCESS(TM), SOFTWARE RELEASE 4.11P, a class II device, cleared for Diasonics, Inc. on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 42 510(k) clearances for Diasonics, Inc., from to . As of , FDA records show no recalls naming K896637.

Clearance record

Decision date
Received
(59 days to decision)
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation
21 CFR 888.3358
Device class
Class II
Review panel
Orthopedic
Applicant
Diasonics, Inc. 280 Utah Ave., S. San Francisco CA
Third party review
No

Clearances, product code LPH

Trailing 12 months
11 clearances under product code LPH in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LPH, trailing twelve months
MonthClearances
November 20252
December 20251
January 20261
February 20261
March 20260
April 20260
May 20261
June 20261
July 20261
August 20262
September 20261
October 20260