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FDA 510(k)

150 DRIVER REAMER

K-Number: K812437 · 1981-11-02

ApplicantBlack & Decker(Tm)
Decision Date1981-11-02
Product CodeGEY
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 1981-11-02 under 510(k) number K812437. The device is classified under product code GEY. 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 1981-11-02. The listed applicant is Black & Decker(Tm). The 510(k) number is K812437.

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

150 DRIVER REAMER received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812437.

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 GEY.

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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 PACKK812436450/800 DRILLK812439DUAL MPC CHARGERK812438SAGITTAL SAWK800314POWER PACK

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Related Devices (Code: GEY)

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.

K050519ADVANCED TURBO DRIVE SYSTEMLinvatec Corp.K020621ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDSArthrocare Corp.K012738SYMPHONY GRAFT DELIVERY SYSTEM (GDS)DepuyacromedK972308MEDNEXT 1000 DRILLMednext, Inc.K971941AQUA SPRAYBoyd Industries, Inc.K971782BONE AND MARROW COLLECTION SYSTEM KITBiomedical Ent., 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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