INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES— 510(k) K072600

Name: FDA 510(k) clearance K072600
Creator: U.S. Food and Drug Administration
Published: 2008-05-19

Substantially Equivalent

Sunlight Medical, Inc.

FDA 510(k) clearance K072600 for INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES, Substantially Equivalent on 2008-05-19. Applicant: Sunlight Medical, Inc.. Device class: 2.

Clearance details

Applicant: Sunlight Medical, Inc.
Product code: Code MQH
Device class: Class 2
Regulation: 21 CFR 884.6130
Advisory panel: Obstetrics/Gynecology
Date received: 2007-09-14
Decision date: 2008-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQH

view all

K250838 — Denudation Pipettes2025-07-03
K192146 — V-DENUPET2020-01-28
K161275 — EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip2017-01-23
K152581 — LifeGlobal Micro Tips2016-04-11
K151018 — Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette2016-01-08

More clearances from Sunlight Medical, Inc.

view all

K092554 — BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES2010-04-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.