About This 510(k) Submission
K983596 is an FDA 510(k) clearance for the INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING, a Microtools, Assisted Reproduction (pipettes) (Class II — Special Controls, product code MQH), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on February 5, 1999, 115 days after receiving the submission on October 13, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6130.