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FDA 510(k)

KNIFE, OPHTHALMIC

K-Number: K871285 · 1987-04-27

ApplicantTrueline Instruments, Inc.
Decision Date1987-04-27
Product CodeHNN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KNIFE, OPHTHALMIC is the device name listed in this FDA 510(k) record. The listed applicant is Trueline Instruments, Inc.. It received FDA 510(k) clearance on 1987-04-27 under 510(k) number K871285. 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 KNIFE, OPHTHALMIC?

KNIFE, OPHTHALMIC is a medical device that received FDA 510(k) clearance on 1987-04-27. The listed applicant is Trueline Instruments, Inc.. The 510(k) number is K871285.

When did KNIFE, OPHTHALMIC receive FDA 510(k) clearance?

KNIFE, OPHTHALMIC received FDA 510(k) clearance on 1987-04-27, under 510(k) number K871285.

Who is the listed applicant for KNIFE, OPHTHALMIC?

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

What is the FDA product code for KNIFE, OPHTHALMIC?

The FDA product code for KNIFE, OPHTHALMIC 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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