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FDA 510(k)

SURGICAL NEEDLE GUIDE

K-Number: K890228 · 1989-01-27

ApplicantKinetic Medical Products
Decision Date1989-01-27
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL NEEDLE GUIDE 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 1989-01-27 under 510(k) number K890228. The device is classified under product code GDF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL NEEDLE GUIDE?

SURGICAL NEEDLE GUIDE is a medical device that received FDA 510(k) clearance on 1989-01-27. The listed applicant is Kinetic Medical Products. The 510(k) number is K890228.

When did SURGICAL NEEDLE GUIDE receive FDA 510(k) clearance?

SURGICAL NEEDLE GUIDE received FDA 510(k) clearance on 1989-01-27, under 510(k) number K890228.

Who is the listed applicant for SURGICAL NEEDLE GUIDE?

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 SURGICAL NEEDLE GUIDE?

The FDA product code for SURGICAL NEEDLE GUIDE is GDF.

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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: GDF)

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.

K031173NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc.K950311GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIREGlobal Medical Products, Ltd.K950007SURGICAL INSTRUMENT GUIDEUnited States Surgical, A Division of Tyco HealthcK945124BREAST LESION LOCALIZATION NEEDLEPromex, Inc.K944942BREAST LESION LOCALIZATION NEEDLEPromedical , Ltd.K935538BAUER TEMNO COAXIAL NEEDLEBauer Medical, 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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