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FDA 510(k)

SMARTKNIFE SYSTEM

K-Number: K853063 · 1985-11-04

ApplicantCooperVision, Inc.
Decision Date1985-11-04
Product CodeHNN
Advisory CommitteeOP
DecisionSubstantially Equivalent for Some Indications

Device Summary

SMARTKNIFE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 1985-11-04 under 510(k) number K853063. The device is classified under product code HNN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SMARTKNIFE SYSTEM?

SMARTKNIFE SYSTEM is a medical device that received FDA 510(k) clearance on 1985-11-04. The listed applicant is CooperVision, Inc.. The 510(k) number is K853063.

When did SMARTKNIFE SYSTEM receive FDA 510(k) clearance?

SMARTKNIFE SYSTEM received FDA 510(k) clearance on 1985-11-04, under 510(k) number K853063.

Who is the listed applicant for SMARTKNIFE SYSTEM?

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

What is the FDA product code for SMARTKNIFE SYSTEM?

The FDA product code for SMARTKNIFE SYSTEM is HNN.

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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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