510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K864524Substantially Equivalent

Sperm Select(tm)

Pharmacia, Inc., Piscataway NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864524 is the FDA 510(k) clearance record for SPERM SELECT(TM), a class II device, cleared for Pharmacia, Inc. on under FDA product code MQL (Media, Reproductive). FDA records list 129 510(k) clearances for Pharmacia, Inc., from to . As of , FDA records show no recalls naming K864524.

Clearance record

Decision date
Received
(77 days to decision)
Product code
MQL Media, Reproductive
Regulation
21 CFR 884.6180
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Pharmacia, Inc. 800 Centennial Ave., Piscataway NJ
Third party review
No

Clearances, product code MQL

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