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FDA 510(k)

GYNECOLOGIC EXAMINATION KIT

K-Number: K894489 · 1989-10-05

ApplicantA & A Medical, Inc.
Decision Date1989-10-05
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNECOLOGIC EXAMINATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is A & A Medical, Inc.. It received FDA 510(k) clearance on 1989-10-05 under 510(k) number K894489. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNECOLOGIC EXAMINATION KIT?

GYNECOLOGIC EXAMINATION KIT is a medical device that received FDA 510(k) clearance on 1989-10-05. The listed applicant is A & A Medical, Inc.. The 510(k) number is K894489.

When did GYNECOLOGIC EXAMINATION KIT receive FDA 510(k) clearance?

GYNECOLOGIC EXAMINATION KIT received FDA 510(k) clearance on 1989-10-05, under 510(k) number K894489.

Who is the listed applicant for GYNECOLOGIC EXAMINATION KIT?

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

What is the FDA product code for GYNECOLOGIC EXAMINATION KIT?

The FDA product code for GYNECOLOGIC EXAMINATION KIT is HIB.

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Other records listing A & A 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.

K013437SF SH CATHETER, MODEL R65-945K013491HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948K003949TACKER, MODEL R65-933K011512MMODIFICATION TO LAMINARIAK010510BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1K010789CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1

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Related Devices (Code: HIB)

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.

K252208JFord Speculum Sleeve™Ford Medtech, LLCK130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLCK120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI LtdaK092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation

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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