510(k) K072600
- Device
- INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES
- Applicant
- SUNLIGHT MEDICAL, INC.
- 510(k) number
- K072600
- Product code
- MQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-05-19
- Date received
- 2007-09-14
- Regulation
- 884.6130
- Classification name
- Microtools, Assisted Reproduction (pipettes)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DUNSONG YANG
- Address
- 12443 San Jose Blvd. Suite 602 Jacksonville FL US 32223 32223
FDA Registration Numbers#
- 1058584
- 1825146
- 2245304
- 3042228693
- 3016126174
- 3014755376
- 2522007
- 1036836
- 3003744503
- 3007086345
- 3033740404
- 2029275
- 1000393132
- 1319660
- 3014295858
- 3008812251
- 3016214552
- 2246552
- 1220477
- 1820334
- 3006017180
- 1216677
- 3007293046
- 3010187826
Source Documents#
Other 510(k) Records For Product Code MQH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250838 | Denudation Pipettes | Guangzhou Pinzhi Medical Device Co., Ltd. | 2025-07-03 |
| K192146 | V-DENUPET | Vitromed GmbH | 2020-01-28 |
| K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | Research Instruments Limited | 2017-01-23 |
| K152581 | LifeGlobal Micro Tips | Life Global Group, LLC | 2016-04-11 |
| K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette | Cook Incorporated | 2016-01-08 |
| K150748 | Flexipet Denuding Pipette, Flexipet Manipulation Pipette | Cook Incorporated | 2015-12-18 |
| K133257 | BIOPSY PIPETTES | Research Instruments , Ltd. | 2014-05-16 |
| K102480 | INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA | Jieying Laboratory, Inc. | 2011-04-19 |
| K092554 | BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES | Sunlight Medical, Inc. | 2010-04-30 |
| K041435 | THE STRIPPER PGD | Mid-Atlantic Diagnostics, Inc. | 2004-09-29 |
| K041562 | CRYOTIP | Irvine Scientific Sales Co., Inc. | 2004-08-09 |
| K033903 | MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, | Cook Urological, Inc. | 2004-01-16 |
| K033904 | PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) | Cook Urological, Inc. | 2004-01-16 |
| K024302 | PRECISION CAPILLARIES FOR MICROMANIPULATION | Brinkmann Instruments, Inc. | 2003-02-19 |
| K022643 | BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 | Swemed Lab International AB | 2002-11-05 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases