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FDA 510(k)

VAN DELLEN IRRIGATING CYSTOTOME

K-Number: K873163 · 1987-09-04

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

Device Summary

VAN DELLEN IRRIGATING CYSTOTOME 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 K873163. The device is classified under product code HNY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAN DELLEN IRRIGATING CYSTOTOME?

VAN DELLEN IRRIGATING CYSTOTOME 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 K873163.

When did VAN DELLEN IRRIGATING CYSTOTOME receive FDA 510(k) clearance?

VAN DELLEN IRRIGATING CYSTOTOME received FDA 510(k) clearance on 1987-09-04, under 510(k) number K873163.

Who is the listed applicant for VAN DELLEN IRRIGATING CYSTOTOME?

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 IRRIGATING CYSTOTOME?

The FDA product code for VAN DELLEN IRRIGATING CYSTOTOME is HNY.

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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 CANNULAK873162VAN DELLEN RETROBULBAR NEEDLE

View all 7 devices →

Related Devices (Code: HNY)

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.

K961524STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORSSterilab, Inc.K880345CYSTOTOMES/KNIFESMyocure, Inc.K874975PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOMEAdvanced Surgical Products, Inc.K874983PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874997PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874993PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOMEAdvanced Surgical Products, 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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