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FDA 510(k)

ARTHROSCOPIC SURGICAL POWER DEVICE

K-Number: K863696 · 1986-09-29

ApplicantAmerican Edwards Laboratories
Decision Date1986-09-29
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ARTHROSCOPIC SURGICAL POWER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1986-09-29 under 510(k) number K863696. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHROSCOPIC SURGICAL POWER DEVICE?

ARTHROSCOPIC SURGICAL POWER DEVICE is a medical device that received FDA 510(k) clearance on 1986-09-29. The listed applicant is American Edwards Laboratories. The 510(k) number is K863696.

When did ARTHROSCOPIC SURGICAL POWER DEVICE receive FDA 510(k) clearance?

ARTHROSCOPIC SURGICAL POWER DEVICE received FDA 510(k) clearance on 1986-09-29, under 510(k) number K863696.

Who is the listed applicant for ARTHROSCOPIC SURGICAL POWER DEVICE?

The FDA 510(k) record lists American Edwards Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTHROSCOPIC SURGICAL POWER DEVICE?

The FDA product code for ARTHROSCOPIC SURGICAL POWER DEVICE is KIT.

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Other records listing American Edwards Laboratories 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.

K873485EDSLAB (R) OCCLUSION BALLOON CATHETERK872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2K870444HOMEPRO II VOLUMETRIC INFUSION PUMPK864997MEDTRAC VP VOLUMETRIC INFUSION PUMPK864330SHEAR FORCE GAUGE

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Related Devices (Code: KIT)

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.

K892938AMNIO-GROW TMInovar Biologicals, Inc.K890700MELANOCYTE GROWTH MEDIUM (MGM)Clonetics Corp.K890701ENDOTHELIAL GROWTH MEDIUM (EGM)Clonetics Corp.K890482ABC, ABC-1X, ABC(TM)Cell Ent., Inc.K884654ALPHACALF SERUMHyclone Laboratories, Inc.K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382Sigma Chemical Co.

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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