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FDA 510(k)

A.C.L. GUIDE KIT

K-Number: K862564 · 1986-08-18

ApplicantAspen Laboratories, Inc.
Decision Date1986-08-18
Product CodeFZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

A.C.L. GUIDE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Laboratories, Inc.. It received FDA 510(k) clearance on 1986-08-18 under 510(k) number K862564. The device is classified under product code FZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A.C.L. GUIDE KIT?

A.C.L. GUIDE KIT is a medical device that received FDA 510(k) clearance on 1986-08-18. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K862564.

When did A.C.L. GUIDE KIT receive FDA 510(k) clearance?

A.C.L. GUIDE KIT received FDA 510(k) clearance on 1986-08-18, under 510(k) number K862564.

Who is the listed applicant for A.C.L. GUIDE KIT?

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

What is the FDA product code for A.C.L. GUIDE KIT?

The FDA product code for A.C.L. GUIDE KIT is FZX.

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Other records listing Aspen Laboratories, 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.

K981220SYSTEM 7500 ABC ELECTROSURGICAL UNITK963088SHEATH, ELECTROSURGICAL PENCILK955834SYSTEM 6500 ABC ELECTROSURGICAL UNITK9602964000 ETMK953081BEAMER PLUSK953007EXCALIBUR PLUS ELECTROSURGICAL UNIT

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Related Devices (Code: FZX)

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.

K914715PARALLELING GUIDESImplant Corp. of AmericaK871413CIVCO STEPPERCIVCO Medical Instruments Co., Inc.K871503BIOPSY NEEDLE GUIDE KIT, STERILEAmedic USAK854262MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLYMeadox Surgimed, Inc.K852402NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZERNorth American Instrument Corp.K842698BRITISH SPINAL FUSION SETDowns Surgical , Ltd.

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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