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FDA 510(k)

SURGICAL KNIFE

K-Number: K834546 · 1984-03-16

ApplicantFine-Cut Diamond Instruments
Decision Date1984-03-16
Product CodeHNN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SURGICAL KNIFE is the device name listed in this FDA 510(k) record. The listed applicant is Fine-Cut Diamond Instruments. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K834546. The device is classified under product code HNN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL KNIFE?

SURGICAL KNIFE is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Fine-Cut Diamond Instruments. The 510(k) number is K834546.

When did SURGICAL KNIFE receive FDA 510(k) clearance?

SURGICAL KNIFE received FDA 510(k) clearance on 1984-03-16, under 510(k) number K834546.

Who is the listed applicant for SURGICAL KNIFE?

The FDA 510(k) record lists Fine-Cut Diamond Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL KNIFE?

The FDA product code for SURGICAL KNIFE is HNN.

Related Clinical Trials

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Related Devices (Code: HNN)

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.

K110166CLEARCUT S SAFETY KNIFEAlcon Research, Ltd.K922378OPHTHALMIC KNIFEMicroptics Development LaboratoryK882402RETRACTIVE INCISION MICROMETER (RIM) GUAGEOptical CenterK881669MVR/STILETTO BLADE 20GA. - P/N 1900Advanced Surgical Products, Inc.K874979PRISMA DISPOSABLE MVR/STILETTO BLADEAdvanced Surgical Products, Inc.K874057OPHTHALMIC TIP & BLADE SCALPELSMyocure, 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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