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FDA 510(k)

MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM

K-Number: K000444 · 2000-04-21

ApplicantPrism Enterprises, Inc.
Decision Date2000-04-21
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Prism Enterprises, Inc.. It received FDA 510(k) clearance on 2000-04-21 under 510(k) number K000444. 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 MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM?

MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM is a medical device that received FDA 510(k) clearance on 2000-04-21. The listed applicant is Prism Enterprises, Inc.. The 510(k) number is K000444.

When did MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM receive FDA 510(k) clearance?

MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM received FDA 510(k) clearance on 2000-04-21, under 510(k) number K000444.

Who is the listed applicant for MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM?

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

What is the FDA product code for MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM?

The FDA product code for MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM is HIB.

Related Clinical Trials

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Other records listing Prism Enterprises, 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.

K030283BABY PODK020447MITYVAC MERLIN, MODEL 10027K011532MITYVAC

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.

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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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