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FDA 510(k)

SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM

K-Number: K931395 · 1994-01-28

ApplicantMicro Surgical Instruments Corp.
Decision Date1994-01-28
Product CodeKIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Micro Surgical Instruments Corp.. It received FDA 510(k) clearance on 1994-01-28 under 510(k) number K931395. The device is classified under product code KIJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM?

SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-28. The listed applicant is Micro Surgical Instruments Corp.. The 510(k) number is K931395.

When did SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM receive FDA 510(k) clearance?

SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM received FDA 510(k) clearance on 1994-01-28, under 510(k) number K931395.

Who is the listed applicant for SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM?

The FDA 510(k) record lists Micro Surgical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM?

The FDA product code for SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM is KIJ.

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Other records listing Micro Surgical Instruments Corp. 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.

K932492IMPLANTOLOGY MODULE, MODEL 2175K930205ELECTRIC WIRE DRIVER, MODEL 2640EK914998MICROAIRE(R) FACIAL BONE PLATING SYSTEMK915139MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULEK914346DRILL MODULES MODELS 2116/2117K913369MICRO-AIRE MODEL 2060

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Related Devices (Code: KIJ)

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.

K163308SMARTOJeil Medical CorporationK112599INSURGICAL SINGLE USE POWER EQUIPMENTInsurgical, LLCK101563SMARTOJeil Medical CorporationK972367STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTStryker InstrumentsK970378STRYKER 2115 REPLACEMENT BATTERY (2115)Implant Resource, Inc.K960711ACUMED BONE GRAFT SYSTEMAcu Med, 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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