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FDA 510(k)

BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES

K-Number: K092554 · 2010-04-30

ApplicantSunlight Medical, Inc.
Decision Date2010-04-30
Product CodeMQH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES is the device name listed in this FDA 510(k) record. The listed applicant is Sunlight Medical, Inc.. It received FDA 510(k) clearance on 2010-04-30 under 510(k) number K092554. The device is classified under product code MQH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES?

BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES is a medical device that received FDA 510(k) clearance on 2010-04-30. The listed applicant is Sunlight Medical, Inc.. The 510(k) number is K092554.

When did BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES receive FDA 510(k) clearance?

BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES received FDA 510(k) clearance on 2010-04-30, under 510(k) number K092554.

Who is the listed applicant for BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES?

The FDA 510(k) record lists Sunlight Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES?

The FDA product code for BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES is MQH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Sunlight Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K072600INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES

Related Devices (Code: MQH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250838Denudation PipettesGuangzhou Pinzhi Medical Device Co., Ltd.K192146V-DENUPETVitromed GmbHK161275EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripResearch Instruments LimitedK152581LifeGlobal Micro TipsLife Global Group, LLCK151018Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction PipetteCook IncorporatedK102480INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HAJieying Laboratory, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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