510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K991388Substantially Equivalent

Assisted Hatching Micropipettes, Denuding Pipettes, Holding Micropipettes, Icsi Micropipettes, Partial Zone Dissection M

Pacific Andrology, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991388 is the FDA 510(k) clearance record for ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M, a class II device, cleared for Pacific Andrology, Inc. on under FDA product code MQH (Microtools, Assisted Reproduction (Pipettes)). FDA records list 2 510(k) clearances for Pacific Andrology, Inc., from to . As of , FDA records show no recalls naming K991388.

Clearance record

Decision date
Received
(145 days to decision)
Product code
MQH Microtools, Assisted Reproduction (Pipettes)
Regulation
21 CFR 884.6130
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Pacific Andrology, Inc. 3722 Ave. Sausalito, Irvine CA
510(k) summary
Statement
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