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FDA 510(k)

MITYVAC

K-Number: K011532 · 2001-07-30

ApplicantPrism Enterprises, Inc.
Decision Date2001-07-30
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MITYVAC 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 2001-07-30 under 510(k) number K011532. The device is classified under product code HDB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITYVAC?

MITYVAC is a medical device that received FDA 510(k) clearance on 2001-07-30. The listed applicant is Prism Enterprises, Inc.. The 510(k) number is K011532.

When did MITYVAC receive FDA 510(k) clearance?

MITYVAC received FDA 510(k) clearance on 2001-07-30, under 510(k) number K011532.

Who is the listed applicant for MITYVAC?

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 MITYVAC?

The FDA product code for MITYVAC is HDB.

Related Clinical Trials

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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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 10027K000444MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM

Related Devices (Code: HDB)

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.

K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)Clinical Innovations, LLCK041579MEDELA SINGLE USE SILC CUP, MODEL 077.0791Medela AGK043614VACULINK, MODEL VCL 3000Medevco, Inc.K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #1300Fortune Medical Instrument Corp.K020447MITYVAC MERLIN, MODEL 10027Prism Enterprises, Inc.K013460SWIFT LOW PROFILE CUP (PRO CUP)Swift Delivery Products

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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