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FDA 510(k)

AUTOMATED VITRECTOMY DEVICE

K-Number: K961078 · 1996-06-14

ApplicantPromex, Inc.
Decision Date1996-06-14
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AUTOMATED VITRECTOMY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Promex, Inc.. It received FDA 510(k) clearance on 1996-06-14 under 510(k) number K961078. 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 AUTOMATED VITRECTOMY DEVICE?

AUTOMATED VITRECTOMY DEVICE is a medical device that received FDA 510(k) clearance on 1996-06-14. The listed applicant is Promex, Inc.. The 510(k) number is K961078.

When did AUTOMATED VITRECTOMY DEVICE receive FDA 510(k) clearance?

AUTOMATED VITRECTOMY DEVICE received FDA 510(k) clearance on 1996-06-14, under 510(k) number K961078.

Who is the listed applicant for AUTOMATED VITRECTOMY DEVICE?

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

What is the FDA product code for AUTOMATED VITRECTOMY DEVICE?

The FDA product code for AUTOMATED VITRECTOMY DEVICE is HQE.

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Other records listing Promex, 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.

K023450BIOPSY SITE TISSUE MARKER DEVICEK022634CO-AXIAL INTRODUCER NEEDLEK010400VACUUM ASSISTED CORE BIOPSY DEVICEK011270AUTOMATED CORE BIOPSY DEVICEK001132BONE BIOPSY NEEDLEK994272AUTOMATED CORE BIOPSY DEVICE

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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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