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FDA 510(k)

150 DRIVER/REAMER

K-Number: K800312 · 1980-02-22

ApplicantBlack & Decker(Tm)
Decision Date1980-02-22
Product CodeKIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

150 DRIVER/REAMER is the device name listed in this FDA 510(k) record. The listed applicant is Black & Decker(Tm). It received FDA 510(k) clearance on 1980-02-22 under 510(k) number K800312. 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 150 DRIVER/REAMER?

150 DRIVER/REAMER is a medical device that received FDA 510(k) clearance on 1980-02-22. The listed applicant is Black & Decker(Tm). The 510(k) number is K800312.

When did 150 DRIVER/REAMER receive FDA 510(k) clearance?

150 DRIVER/REAMER received FDA 510(k) clearance on 1980-02-22, under 510(k) number K800312.

Who is the listed applicant for 150 DRIVER/REAMER?

The FDA 510(k) record lists Black & Decker(Tm) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 150 DRIVER/REAMER?

The FDA product code for 150 DRIVER/REAMER is KIJ.

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 Black & Decker(Tm) 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.

K820351CAST CUTTER/CAST SAW/INSTRUMENTK812440POWER PACKK812437150 DRIVER REAMERK812436450/800 DRILLK812439DUAL MPC CHARGERK812438SAGITTAL SAW

View all 11 devices →

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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