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FDA 510(k)

UMBICUT

K-Number: K000227 · 2000-04-27

ApplicantPollak (Intl.), Ltd.
Decision Date2000-04-27
Product CodeHFW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UMBICUT is the device name listed in this FDA 510(k) record. The listed applicant is Pollak (Intl.), Ltd.. It received FDA 510(k) clearance on 2000-04-27 under 510(k) number K000227. The device is classified under product code HFW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UMBICUT?

UMBICUT is a medical device that received FDA 510(k) clearance on 2000-04-27. The listed applicant is Pollak (Intl.), Ltd.. The 510(k) number is K000227.

When did UMBICUT receive FDA 510(k) clearance?

UMBICUT received FDA 510(k) clearance on 2000-04-27, under 510(k) number K000227.

Who is the listed applicant for UMBICUT?

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

What is the FDA product code for UMBICUT?

The FDA product code for UMBICUT is HFW.

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Other records listing Pollak (Intl.), Ltd. 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.

K810049PEDICAT*K810050VECAFIX*K802011INFUSSION ALARM SYSTEM I.A.S. CAT.#1118K802009FLOWCLAMP CAT.#1011 & 1012K802017DRESSING CHANGE SET CAT.#910-930K802007PEDIWET=GUAZE IMPREGNATED WITH PETROL

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Related Devices (Code: HFW)

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.

K041332JOEY CLAMP OPENING TOOLMaternus, Inc.K033846KAEN YIH UMBILICAL CORD CLAMPKaen Yih Enterprise Co., Ltd.K020718SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILEPrecision Dynamics Corp.K021055BUSSE UMBILICAL CORD CLAMP CUTTERBusse Hospital Disposables, Inc.K012917DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-BDynarex Corp.K011621KOALA CLAMP, KOALA CLAMP AND CUTTERMaternus, 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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