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FDA 510(k)

MICROSPAN INSEMINATION SYSTEM

K-Number: K970750 · 1997-05-05

ApplicantImagyn Medical, Inc.
Decision Date1997-05-05
Product CodeMFD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MICROSPAN INSEMINATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Imagyn Medical, Inc.. It received FDA 510(k) clearance on 1997-05-05 under 510(k) number K970750. 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 MICROSPAN INSEMINATION SYSTEM?

MICROSPAN INSEMINATION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-05-05. The listed applicant is Imagyn Medical, Inc.. The 510(k) number is K970750.

When did MICROSPAN INSEMINATION SYSTEM receive FDA 510(k) clearance?

MICROSPAN INSEMINATION SYSTEM received FDA 510(k) clearance on 1997-05-05, under 510(k) number K970750.

Who is the listed applicant for MICROSPAN INSEMINATION SYSTEM?

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

What is the FDA product code for MICROSPAN INSEMINATION SYSTEM?

The FDA product code for MICROSPAN INSEMINATION SYSTEM is MFD.

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Other records listing Imagyn 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.

K972426MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATHK971255IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCERK965055IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPESK963580IMAGYN FALLOPOSCOPY SYSTEMK961688MICROSPAN HYSTEROSCOPEK961506MICROSPAN HYSTEROSCOPE SHEATH

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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.K980061EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTERRocket Medical Plc

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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