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FDA 510(k)

BURS FOR MICRO SURGICAL DRILL SYSTEM

K-Number: K853658 · 1985-09-24

ApplicantAcumed Instruments Corp.
Decision Date1985-09-24
Product CodeGFF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BURS FOR MICRO SURGICAL DRILL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acumed Instruments Corp.. It received FDA 510(k) clearance on 1985-09-24 under 510(k) number K853658. The device is classified under product code GFF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BURS FOR MICRO SURGICAL DRILL SYSTEM?

BURS FOR MICRO SURGICAL DRILL SYSTEM is a medical device that received FDA 510(k) clearance on 1985-09-24. The listed applicant is Acumed Instruments Corp.. The 510(k) number is K853658.

When did BURS FOR MICRO SURGICAL DRILL SYSTEM receive FDA 510(k) clearance?

BURS FOR MICRO SURGICAL DRILL SYSTEM received FDA 510(k) clearance on 1985-09-24, under 510(k) number K853658.

Who is the listed applicant for BURS FOR MICRO SURGICAL DRILL SYSTEM?

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

What is the FDA product code for BURS FOR MICRO SURGICAL DRILL SYSTEM?

The FDA product code for BURS FOR MICRO SURGICAL DRILL SYSTEM is GFF.

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Other records listing Acumed 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.

K863627MICRO SURGICAL DRILL SYSTEMK853659POWERED IRRIGATION FOR MICRO SURGICAL DRILLK853660MICRO SURGICAL DRILL SYSTEMK791891ACU-MED RED MISER HEMOTHORAX BLOOD COLL.K791399ACU-ALERTK791400GASTRIC LAVAGE KIT-DISPOSABLE

View all 8 devices →

Related Devices (Code: GFF)

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.

K974025ANSPACH SHIELDED ATTACHMENTThe Anspach Effort, Inc.K950449SURGICAL BURTransidyne General Corp.K943758SURGICAL BURKomet MedicalK934583BURRSAmerican Medical Specialties, Inc.K894438MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTSMicro-Aire Surgical Instruments, Inc.K890090DANEK IRRIGATING BURR (DIB) SETDanek Medical, 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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