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FDA 510(k)

VAN DELLEN RETROBULBAR NEEDLE

K-Number: K873162 · 1987-09-04

ApplicantVan Dellen, Ltd.
Decision Date1987-09-04
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VAN DELLEN RETROBULBAR NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Van Dellen, Ltd.. It received FDA 510(k) clearance on 1987-09-04 under 510(k) number K873162. The device is classified under product code HMX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAN DELLEN RETROBULBAR NEEDLE?

VAN DELLEN RETROBULBAR NEEDLE is a medical device that received FDA 510(k) clearance on 1987-09-04. The listed applicant is Van Dellen, Ltd.. The 510(k) number is K873162.

When did VAN DELLEN RETROBULBAR NEEDLE receive FDA 510(k) clearance?

VAN DELLEN RETROBULBAR NEEDLE received FDA 510(k) clearance on 1987-09-04, under 510(k) number K873162.

Who is the listed applicant for VAN DELLEN RETROBULBAR NEEDLE?

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

What is the FDA product code for VAN DELLEN RETROBULBAR NEEDLE?

The FDA product code for VAN DELLEN RETROBULBAR NEEDLE is HMX.

Related Clinical Trials

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Other records listing Van Dellen, Ltd. 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.

K873465VAN DELLEN BACTERIA FILTERK873463VAN DELLEN ASPIRATING TUBINGK873464VAN DELLEN CANNULAK873462VAN DELLEN ASPIRATORK873164VAN DELLEN HEALON CANNULAK873163VAN DELLEN IRRIGATING CYSTOTOME

View all 7 devices →

Related Devices (Code: HMX)

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.

K010305WEISS RETINAL CANNULAMicron Surgical, Inc.K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESRetinalabs.ComK970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)American Medical Devices, Inc.K943932STERISEAL OPHTHALMIC CANNULAPharma-Plast, Ltd.K942403INFUSION CANNULAMicrosurgical Technology, Inc.K934844INTER TIP TMicrosurgical Technology, 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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