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FDA 510(k)

CIVCO STEPPER

K-Number: K871413 · 1987-07-14

ApplicantCIVCO Medical Instruments Co., Inc.
Decision Date1987-07-14
Product CodeFZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CIVCO STEPPER is the device name listed in this FDA 510(k) record. The listed applicant is CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 1987-07-14 under 510(k) number K871413. 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 CIVCO STEPPER?

CIVCO STEPPER is a medical device that received FDA 510(k) clearance on 1987-07-14. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K871413.

When did CIVCO STEPPER receive FDA 510(k) clearance?

CIVCO STEPPER received FDA 510(k) clearance on 1987-07-14, under 510(k) number K871413.

Who is the listed applicant for CIVCO STEPPER?

The FDA 510(k) record lists CIVCO Medical Instruments Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CIVCO STEPPER?

The FDA product code for CIVCO STEPPER is FZX.

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Other records listing CIVCO Medical Instruments Co., Inc. as applicant

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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 AmericaK871503BIOPSY NEEDLE GUIDE KIT, STERILEAmedic USAK862564A.C.L. GUIDE KITAspen Laboratories, Inc.K854262MEADOX 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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