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FDA 510(k)

PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM

K-Number: K880150 · 1988-03-04

ApplicantDyonics, Inc.
Decision Date1988-03-04
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dyonics, Inc.. It received FDA 510(k) clearance on 1988-03-04 under 510(k) number K880150. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM?

PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1988-03-04. The listed applicant is Dyonics, Inc.. The 510(k) number is K880150.

When did PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM receive FDA 510(k) clearance?

PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM received FDA 510(k) clearance on 1988-03-04, under 510(k) number K880150.

Who is the listed applicant for PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM?

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 PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM?

The FDA product code for PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM is HWE.

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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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Related Devices (Code: HWE)

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.

K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions LimitedK063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer TrabecularK043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven Medical

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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