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FDA 510(k)

NOVASYS TRANSURETHRAL RF SYSTEM

K-Number: K042132 · 2004-12-21

ApplicantNovasys Medical, Inc.
Decision Date2004-12-21
Product CodeNVJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NOVASYS TRANSURETHRAL RF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Novasys Medical, Inc.. It received FDA 510(k) clearance on 2004-12-21 under 510(k) number K042132. The device is classified under product code NVJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVASYS TRANSURETHRAL RF SYSTEM?

NOVASYS TRANSURETHRAL RF SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-21. The listed applicant is Novasys Medical, Inc.. The 510(k) number is K042132.

When did NOVASYS TRANSURETHRAL RF SYSTEM receive FDA 510(k) clearance?

NOVASYS TRANSURETHRAL RF SYSTEM received FDA 510(k) clearance on 2004-12-21, under 510(k) number K042132.

Who is the listed applicant for NOVASYS TRANSURETHRAL RF SYSTEM?

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

What is the FDA product code for NOVASYS TRANSURETHRAL RF SYSTEM?

The FDA product code for NOVASYS TRANSURETHRAL RF SYSTEM is NVJ.

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Other records listing Novasys Medical, 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.

K013730ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIESK001328INTRODUCER SHEATHK001150ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEEK001151ELECTROSURGICAL ELECTRODE FAMILY

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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