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FDA 510(k)

ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION

K-Number: K940176 · 1996-04-23

ApplicantAckrad Laboratories
Decision Date1996-04-23
Product CodeMFD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION is the device name listed in this FDA 510(k) record. The listed applicant is Ackrad Laboratories. It received FDA 510(k) clearance on 1996-04-23 under 510(k) number K940176. 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 ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION?

ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION is a medical device that received FDA 510(k) clearance on 1996-04-23. The listed applicant is Ackrad Laboratories. The 510(k) number is K940176.

When did ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION receive FDA 510(k) clearance?

ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION received FDA 510(k) clearance on 1996-04-23, under 510(k) number K940176.

Who is the listed applicant for ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION?

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

What is the FDA product code for ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION?

The FDA product code for ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION is MFD.

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Other records listing Ackrad Laboratories 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.

K021272SIB CATHETER, MODEL 61-7005K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAYK020951H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007K970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERK961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)K952542ACKRAD ESOPHAGEAL BALLOON CATHETER SET

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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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