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FDA 510(k)

POWERCUT GOLD SURGICAL SYSTEM

K-Number: K962022 · 1996-08-05

ApplicantBaxter Healthcare Corp
Decision Date1996-08-05
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POWERCUT GOLD SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1996-08-05 under 510(k) number K962022. 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 POWERCUT GOLD SURGICAL SYSTEM?

POWERCUT GOLD SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-05. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K962022.

When did POWERCUT GOLD SURGICAL SYSTEM receive FDA 510(k) clearance?

POWERCUT GOLD SURGICAL SYSTEM received FDA 510(k) clearance on 1996-08-05, under 510(k) number K962022.

Who is the listed applicant for POWERCUT GOLD SURGICAL SYSTEM?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWERCUT GOLD SURGICAL SYSTEM?

The FDA product code for POWERCUT GOLD SURGICAL SYSTEM is HWE.

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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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