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FDA 510(k)

MECHANICAL CYSTITOME

K-Number: K862709 · 1986-08-01

ApplicantRudolph Beaver, Inc.
Decision Date1986-08-01
Product CodeHNY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MECHANICAL CYSTITOME is the device name listed in this FDA 510(k) record. The listed applicant is Rudolph Beaver, Inc.. It received FDA 510(k) clearance on 1986-08-01 under 510(k) number K862709. 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 MECHANICAL CYSTITOME?

MECHANICAL CYSTITOME is a medical device that received FDA 510(k) clearance on 1986-08-01. The listed applicant is Rudolph Beaver, Inc.. The 510(k) number is K862709.

When did MECHANICAL CYSTITOME receive FDA 510(k) clearance?

MECHANICAL CYSTITOME received FDA 510(k) clearance on 1986-08-01, under 510(k) number K862709.

Who is the listed applicant for MECHANICAL CYSTITOME?

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

What is the FDA product code for MECHANICAL CYSTITOME?

The FDA product code for MECHANICAL CYSTITOME is HNY.

Related Clinical Trials

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.

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Other records listing Rudolph Beaver, 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.

K883361ARTHRO-TRAC(TM)K875030OCU-1K860305BEAVER MICRO-GEM GAUGE BLOCKK852828BEAVER R-K KNIFEK853129BEAVER MULTIPURPOSE SAPPHIRE KNIFE

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.K874993PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874997PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874983PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874975PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOMEAdvanced Surgical Products, 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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