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FDA 510(k)

EAR KNIVES

K-Number: K840764 · 1984-05-21

ApplicantSharpoint, Inc.
Decision Date1984-05-21
Product CodeJYO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EAR KNIVES is the device name listed in this FDA 510(k) record. The listed applicant is Sharpoint, Inc.. It received FDA 510(k) clearance on 1984-05-21 under 510(k) number K840764. The device is classified under product code JYO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EAR KNIVES?

EAR KNIVES is a medical device that received FDA 510(k) clearance on 1984-05-21. The listed applicant is Sharpoint, Inc.. The 510(k) number is K840764.

When did EAR KNIVES receive FDA 510(k) clearance?

EAR KNIVES received FDA 510(k) clearance on 1984-05-21, under 510(k) number K840764.

Who is the listed applicant for EAR KNIVES?

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

What is the FDA product code for EAR KNIVES?

The FDA product code for EAR KNIVES is JYO.

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Other records listing Sharpoint, 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.

K863595COATED SUTURE NEEDLEK861947SURGICAL KNIFEK840855CORNEAL SCLERAL LANCEK840659ANTERIOR CAPSULECTOMY CYSTITOMEK840660POSTERIOR CAPSULOTOMY CYSTITOMEK830522STAINLESS STEEL SUTURE 316L

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Related Devices (Code: JYO)

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.

K910212COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYSTAcoustic Imaging Technologies Corp.K841006EAR KNIFE-VARIOUSPremier Dental Products Co.K833602ROLLER KNIFE-TRANSVERSE -SAGITTALMicrotek Medical, Inc.K823911KNIFE BLADE TIPTreace Medical, Inc.K772372ROLLER KNIFEEdward Weck, Inc.K772384MYRINGOTOMY KNIFEEdward Weck, 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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