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FDA 510(k)

DYONICS STEROTOXIC POSITIONER

K-Number: K790502 · 1979-04-05

ApplicantDyonics, Inc.
Decision Date1979-04-05
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DYONICS STEROTOXIC POSITIONER is the device name listed in this FDA 510(k) record. The listed applicant is Dyonics, Inc.. It received FDA 510(k) clearance on 1979-04-05 under 510(k) number K790502. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYONICS STEROTOXIC POSITIONER?

DYONICS STEROTOXIC POSITIONER is a medical device that received FDA 510(k) clearance on 1979-04-05. The listed applicant is Dyonics, Inc.. The 510(k) number is K790502.

When did DYONICS STEROTOXIC POSITIONER receive FDA 510(k) clearance?

DYONICS STEROTOXIC POSITIONER received FDA 510(k) clearance on 1979-04-05, under 510(k) number K790502.

Who is the listed applicant for DYONICS STEROTOXIC POSITIONER?

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

What is the FDA product code for DYONICS STEROTOXIC POSITIONER?

The FDA product code for DYONICS STEROTOXIC POSITIONER is HAW.

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Other records listing Dyonics, 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.

K900070MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEMK896416DYONICS SHOULDER PORTAL SYSTEMK893136SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTYK890665MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIESK894728DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFEK892062PS3500 ARTHROSCOPIC SURGICAL SYSTEM

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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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