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FDA 510(k)

WALLACE INTRAUTERINE INSEMINATION CATHETER

K-Number: K901530 · 1990-07-23

ApplicantGynescope Corp.
Decision Date1990-07-23
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WALLACE INTRAUTERINE INSEMINATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Gynescope Corp.. It received FDA 510(k) clearance on 1990-07-23 under 510(k) number K901530. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALLACE INTRAUTERINE INSEMINATION CATHETER?

WALLACE INTRAUTERINE INSEMINATION CATHETER is a medical device that received FDA 510(k) clearance on 1990-07-23. The listed applicant is Gynescope Corp.. The 510(k) number is K901530.

When did WALLACE INTRAUTERINE INSEMINATION CATHETER receive FDA 510(k) clearance?

WALLACE INTRAUTERINE INSEMINATION CATHETER received FDA 510(k) clearance on 1990-07-23, under 510(k) number K901530.

Who is the listed applicant for WALLACE INTRAUTERINE INSEMINATION CATHETER?

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

What is the FDA product code for WALLACE INTRAUTERINE INSEMINATION CATHETER?

The FDA product code for WALLACE INTRAUTERINE INSEMINATION CATHETER is EJT.

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Other records listing Gynescope Corp. 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.

K902658GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODESK902657GYNESCOPE LAPAROSCOPIC FORCEPSK902655GYNESCOPE LAPAROSCOPESK902656GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVESK902049CROAK OVARIAN BIOPSY FORCEPK902019MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS

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Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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