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FDA 510(k)

GLAUCOMA MECHANICAL TREPHINE

K-Number: K895813 · 1990-04-30

ApplicantTrek Medical Products, Inc.
Decision Date1990-04-30
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GLAUCOMA MECHANICAL TREPHINE is the device name listed in this FDA 510(k) record. The listed applicant is Trek Medical Products, Inc.. It received FDA 510(k) clearance on 1990-04-30 under 510(k) number K895813. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLAUCOMA MECHANICAL TREPHINE?

GLAUCOMA MECHANICAL TREPHINE is a medical device that received FDA 510(k) clearance on 1990-04-30. The listed applicant is Trek Medical Products, Inc.. The 510(k) number is K895813.

When did GLAUCOMA MECHANICAL TREPHINE receive FDA 510(k) clearance?

GLAUCOMA MECHANICAL TREPHINE received FDA 510(k) clearance on 1990-04-30, under 510(k) number K895813.

Who is the listed applicant for GLAUCOMA MECHANICAL TREPHINE?

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

What is the FDA product code for GLAUCOMA MECHANICAL TREPHINE?

The FDA product code for GLAUCOMA MECHANICAL TREPHINE is HQE.

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Other records listing Trek Medical Products, 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.

K920937COMPUTERIZED PUPILK920944FTS-200 GAS SYSTEMK900808RAPID AUTOMATIC PNEUMOPERITONEUM-IK902784FIBER OPTIC LIGHT SOURCEK882403OPHTHALMIC FLUID INJECTORK875195OPHTHALMIC LIGHT PIPE PICK

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Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, 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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