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FDA 510(k)

EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER

K-Number: K980061 · 1998-03-02

ApplicantRocket Medical Plc
Decision Date1998-03-02
Product CodeMFD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER is the device name listed in this FDA 510(k) record. The listed applicant is Rocket Medical Plc. It received FDA 510(k) clearance on 1998-03-02 under 510(k) number K980061. The device is classified under product code MFD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER?

EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER is a medical device that received FDA 510(k) clearance on 1998-03-02. The listed applicant is Rocket Medical Plc. The 510(k) number is K980061.

When did EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER receive FDA 510(k) clearance?

EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER received FDA 510(k) clearance on 1998-03-02, under 510(k) number K980061.

Who is the listed applicant for EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER?

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

What is the FDA product code for EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER?

The FDA product code for EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER is MFD.

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Other records listing Rocket Medical Plc 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.

K210509Rocket Platinum Cured CathterK163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitK162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitK152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetK123033ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE BK052365CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE

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Related Devices (Code: MFD)

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.

K021438INSEMINATION CATHETER, MODEL 320301Labotect Labor-Technik GottingenK012935THECURVE, ITEM 507Select Medical Systems, Inc.K984306`THE INSEMINATOR' (PROPOSED)Wallach Surgical Devices, Inc.K982630MEDWORKS VISUALIZATION INSEMINATION CATHETERMedworks Corp.K982628MEDWORKS INSEMINATION CATHETERMedworks Corp.K972823MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETERA & A Medical, Inc.

Official Source

View on FDA Database →

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

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