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FDA 510(k)

ASPIRETTE ENDOCERVICAL ASPIRATOR

K-Number: K895403 · 1989-11-29

ApplicantUnimar, Inc.
Decision Date1989-11-29
Product CodeHFC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ASPIRETTE ENDOCERVICAL ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Unimar, Inc.. It received FDA 510(k) clearance on 1989-11-29 under 510(k) number K895403. The device is classified under product code HFC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPIRETTE ENDOCERVICAL ASPIRATOR?

ASPIRETTE ENDOCERVICAL ASPIRATOR is a medical device that received FDA 510(k) clearance on 1989-11-29. The listed applicant is Unimar, Inc.. The 510(k) number is K895403.

When did ASPIRETTE ENDOCERVICAL ASPIRATOR receive FDA 510(k) clearance?

ASPIRETTE ENDOCERVICAL ASPIRATOR received FDA 510(k) clearance on 1989-11-29, under 510(k) number K895403.

Who is the listed applicant for ASPIRETTE ENDOCERVICAL ASPIRATOR?

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

What is the FDA product code for ASPIRETTE ENDOCERVICAL ASPIRATOR?

The FDA product code for ASPIRETTE ENDOCERVICAL ASPIRATOR is HFC.

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Other records listing Unimar, Inc. as applicant

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K932432KRONNER REINFORCING STYLETTEK920803HSG TRAYK910317UNI-SEM(TM)K904473KRONNER MANIPUJECTORK895659HUI MINI-FLEXK894264KDF-2.3

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Related Devices (Code: HFC)

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.

K974032ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATORA & A Medical, Inc.K960263CERVICAL MUCOUS ASPIRATION CATHETERCook Urological, Inc.K954903PEDI VAGINAL ASPIRATORCook Urological, Inc.K954102SELECTMUCUSSelect Medical Systems, Inc.K902242ENDOCERVICAL ASPIRATORInnovative Medical Products, Inc.K902032O. B. PACK IVCustomed, 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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