510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092554Substantially Equivalent

Blastomere Biopsy Pipettes, Polar Body Biopsy Pipettes

Sunlight Medical, Inc., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092554 is the FDA 510(k) clearance record for BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES, a class II device, cleared for Sunlight Medical, Inc. on under FDA product code MQH (Microtools, Assisted Reproduction (Pipettes)). FDA records list 2 510(k) clearances for Sunlight Medical, Inc., from to . As of , FDA records show no recalls naming K092554.

Clearance record

Decision date
Received
(253 days to decision)
Product code
MQH Microtools, Assisted Reproduction (Pipettes)
Regulation
21 CFR 884.6130
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sunlight Medical, Inc. 12443 San Jose Blvd., Jacksonville FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQH

Trailing 12 months

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

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