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FDA 510(k)

MICROSURGICAL KERATOME

K-Number: K890216 · 1989-02-16

ApplicantKinetic Medical Products
Decision Date1989-02-16
Product CodeGZX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MICROSURGICAL KERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Kinetic Medical Products. It received FDA 510(k) clearance on 1989-02-16 under 510(k) number K890216. The device is classified under product code GZX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSURGICAL KERATOME?

MICROSURGICAL KERATOME is a medical device that received FDA 510(k) clearance on 1989-02-16. The listed applicant is Kinetic Medical Products. The 510(k) number is K890216.

When did MICROSURGICAL KERATOME receive FDA 510(k) clearance?

MICROSURGICAL KERATOME received FDA 510(k) clearance on 1989-02-16, under 510(k) number K890216.

Who is the listed applicant for MICROSURGICAL KERATOME?

The FDA 510(k) record lists Kinetic Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROSURGICAL KERATOME?

The FDA product code for MICROSURGICAL KERATOME is GZX.

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Other records listing Kinetic Medical Products 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.

K890385MIDWIFERY/OBSTETRICAL FORCEPSK890380CERVICAL BIOPSY FORCEPSK890387MALLEABLE PLACENTA CURETTEK890382COMPRESSION FORCEPSK890376VAGINAL SPECULUMK890383HYSTERECTOMY FORCEPS

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Related Devices (Code: GZX)

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.

K932169MICROSURGICAL INSTRUMENTSAmerican Russian Medical Services, Inc.K926048CLARUS ENDOSCOPIC BALL PROBEClarus Medical Systems, Inc.K911932J105 JAMES SURGICAL SYSTEM I/A PACKO.R. Specialties, Inc.K873933RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUMDowns Surgical , Ltd.K873934RANGE OF CROCODILE ACTION INSTRUMENTSDowns Surgical , Ltd.K862971MICRA MICROSURGICAL INSTRUMENTSCordis Corp.

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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