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FDA 510(k)

ARTHROBOT BI-FOLD DRAPE

K-Number: K932253 · 1994-02-03

ApplicantAndronic Devices, Ltd.
Decision Date1994-02-03
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHROBOT BI-FOLD DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Andronic Devices, Ltd.. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K932253. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHROBOT BI-FOLD DRAPE?

ARTHROBOT BI-FOLD DRAPE is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Andronic Devices, Ltd.. The 510(k) number is K932253.

When did ARTHROBOT BI-FOLD DRAPE receive FDA 510(k) clearance?

ARTHROBOT BI-FOLD DRAPE received FDA 510(k) clearance on 1994-02-03, under 510(k) number K932253.

Who is the listed applicant for ARTHROBOT BI-FOLD DRAPE?

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

What is the FDA product code for ARTHROBOT BI-FOLD DRAPE?

The FDA product code for ARTHROBOT BI-FOLD DRAPE is KKX.

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Other records listing Andronic Devices, Ltd. 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.

K940812INSIGHT ELECTRONIC ALIGNMENT INDICATORK934928INSITE FILTER & TUBING SETK934926INSITE MODEL 20 & MODEL 15 INSUFFLATORSK935381KAPS POSITIONING ARMK934124AUTOQUOT AUTOMATED ALIQUOTTING SYSTEMK936308ENDEX ENDOSCOPIC POSITIONING SYSTEM

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Related Devices (Code: KKX)

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K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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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