FDA 510(k)

SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO

K-Number: K991700 · 1999-07-19

Decision Date1999-07-19

Product CodeMQH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO is the device name listed in this FDA 510(k) record. The listed applicant is Swemed Lab International AB. It received FDA 510(k) clearance on 1999-07-19 under 510(k) number K991700. 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 SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO?

SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO is a medical device that received FDA 510(k) clearance on 1999-07-19. The listed applicant is Swemed Lab International AB. The 510(k) number is K991700.

When did SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO receive FDA 510(k) clearance?

SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO received FDA 510(k) clearance on 1999-07-19, under 510(k) number K991700.

Who is the listed applicant for SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO?

The FDA 510(k) record lists Swemed Lab International AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO?

The FDA product code for SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO is MQH.

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Other records listing Swemed Lab International AB as applicant

K053208CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET K022643BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 K991273SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE

Related Devices (Code: MQH)

K250838Denudation PipettesGuangzhou Pinzhi Medical Device Co., Ltd.K192146V-DENUPETVitromed GmbH K161275EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripResearch Instruments Limited K152581LifeGlobal Micro TipsLife Global Group, LLC K151018Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction PipetteCook Incorporated K102480INJECTION 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.