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FDA 510(k)

KAPS POSITIONING ARM

K-Number: K935381 · 1994-04-15

ApplicantAndronic Devices, Ltd.
Decision Date1994-04-15
Product CodeFWZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KAPS POSITIONING ARM 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 1994-04-15 under 510(k) number K935381. The device is classified under product code FWZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAPS POSITIONING ARM?

KAPS POSITIONING ARM is a medical device that received FDA 510(k) clearance on 1994-04-15. The listed applicant is Andronic Devices, Ltd.. The 510(k) number is K935381.

When did KAPS POSITIONING ARM receive FDA 510(k) clearance?

KAPS POSITIONING ARM received FDA 510(k) clearance on 1994-04-15, under 510(k) number K935381.

Who is the listed applicant for KAPS POSITIONING ARM?

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 KAPS POSITIONING ARM?

The FDA product code for KAPS POSITIONING ARM is FWZ.

Related Clinical Trials

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.

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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 INSUFFLATORSK934124AUTOQUOT AUTOMATED ALIQUOTTING SYSTEMK936308ENDEX ENDOSCOPIC POSITIONING SYSTEMK932253ARTHROBOT BI-FOLD DRAPE

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Related Devices (Code: FWZ)

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.

K960019RETRACTOR ARM CLAMPBiopsys Medical, Inc.K945415'LIL MAC ACCESSORY CLAMP(TM)D.L. Nelson and Assoc., Inc.K944779CARBON LIGHTS HAND SURGERY TABLEAllen Medical Systems, Inc.K931037WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)Whitmore Ent., Inc.K926225SPONGE COUNTERAmerican Medical Manufacturer, Inc.K925035MIDKIFF GEOSTATIC CLAMPD.L. Nelson and Assoc., Inc.

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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