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FDA 510(k)

PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD

K-Number: K033182 · 2004-01-30

ApplicantSurgin Surgical Instrumentation, Inc.
Decision Date2004-01-30
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD is the device name listed in this FDA 510(k) record. The listed applicant is Surgin Surgical Instrumentation, Inc.. It received FDA 510(k) clearance on 2004-01-30 under 510(k) number K033182. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD?

PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD is a medical device that received FDA 510(k) clearance on 2004-01-30. The listed applicant is Surgin Surgical Instrumentation, Inc.. The 510(k) number is K033182.

When did PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD receive FDA 510(k) clearance?

PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD received FDA 510(k) clearance on 2004-01-30, under 510(k) number K033182.

Who is the listed applicant for PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD?

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

What is the FDA product code for PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD?

The FDA product code for PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD is HNO.

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Other records listing Surgin Surgical Instrumentation, 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.

K082110DUAL SYRINGE HOLDERK033236PRIZM KERATOME BLADE, MODEL MK8512M2K011195PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CBK994015ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508K980849SURGIN KITK954238SURGIN GENISIS HANDPIECE

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Related Devices (Code: HNO)

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.

K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.K172994EPI K ConsoleMoria SAK072102EPIVISION SL SYSTEMGebauer Medizintechnik GmbHK082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KGK062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken Industries

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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