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FDA 510(k)

PEDI VAGINAL ASPIRATOR

K-Number: K954903 · 1996-04-29

ApplicantCook Urological, Inc.
Decision Date1996-04-29
Product CodeHFC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PEDI VAGINAL ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1996-04-29 under 510(k) number K954903. 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 PEDI VAGINAL ASPIRATOR?

PEDI VAGINAL ASPIRATOR is a medical device that received FDA 510(k) clearance on 1996-04-29. The listed applicant is Cook Urological, Inc.. The 510(k) number is K954903.

When did PEDI VAGINAL ASPIRATOR receive FDA 510(k) clearance?

PEDI VAGINAL ASPIRATOR received FDA 510(k) clearance on 1996-04-29, under 510(k) number K954903.

Who is the listed applicant for PEDI VAGINAL ASPIRATOR?

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

What is the FDA product code for PEDI VAGINAL ASPIRATOR?

The FDA product code for PEDI VAGINAL ASPIRATOR is HFC.

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Other records listing Cook Urological, Inc. as applicant

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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.

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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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