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FDA 510(k)

MICRO-CRAFT OSCILLATING SAW HANDPIECE

K-Number: K822790 · 1982-10-22

ApplicantXomed, Inc.
Decision Date1982-10-22
Product CodeKIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICRO-CRAFT OSCILLATING SAW HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1982-10-22 under 510(k) number K822790. 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 MICRO-CRAFT OSCILLATING SAW HANDPIECE?

MICRO-CRAFT OSCILLATING SAW HANDPIECE is a medical device that received FDA 510(k) clearance on 1982-10-22. The listed applicant is Xomed, Inc.. The 510(k) number is K822790.

When did MICRO-CRAFT OSCILLATING SAW HANDPIECE receive FDA 510(k) clearance?

MICRO-CRAFT OSCILLATING SAW HANDPIECE received FDA 510(k) clearance on 1982-10-22, under 510(k) number K822790.

Who is the listed applicant for MICRO-CRAFT OSCILLATING SAW HANDPIECE?

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

What is the FDA product code for MICRO-CRAFT OSCILLATING SAW HANDPIECE?

The FDA product code for MICRO-CRAFT OSCILLATING SAW HANDPIECE is KIJ.

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Other records listing Xomed, Inc. 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.

K002395MODEL 30 CLASSIC PNEUMATONOMETERK002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEK002828XPS NITRO SYSTEMK002897TITANIUM MIDDLE EAR PROSTHESESK993653MICRO-FRANCE TROCARS AND ACCESSORIESK001148MEROGEL OTOLOGIC PACK

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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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