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FDA 510(k)

SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK

K-Number: K935391 · 1994-02-24

Applicant3M Health Care, Sarns
Decision Date1994-02-24
Product CodeGFA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK is the device name listed in this FDA 510(k) record. The listed applicant is 3M Health Care, Sarns. It received FDA 510(k) clearance on 1994-02-24 under 510(k) number K935391. The device is classified under product code GFA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK?

SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK is a medical device that received FDA 510(k) clearance on 1994-02-24. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K935391.

When did SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK receive FDA 510(k) clearance?

SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK received FDA 510(k) clearance on 1994-02-24, under 510(k) number K935391.

Who is the listed applicant for SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK?

The FDA 510(k) record lists 3M Health Care, Sarns as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK?

The FDA product code for SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK is GFA.

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Other records listing 3M Health Care, Sarns as applicant

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K960916SAMS 8000 CARDIOPLEGIA MONITORK953901SARNS 800 ROLLER PUMPK9507393M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEMK941653SARNS TURBO MEMBRANE OXYGENATOR MODIFICATIONK941654SARNS FILTERED VENOUS RESERVIOR MODIFICATIONK940651SARNS ULTRASONIC AIR SENSOR

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Related Devices (Code: GFA)

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.

K971978GRAFT HARVESTING SAWBLADESWrightmedicaltechnologyincK954483STRYKER SAGITTAL SAW ATTACHMENTStryker InstrumentsK955229WRIGHT MEDICAL TECHNOLOGY SAWBLADESWrightmedicaltechnologyincK953012DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLSBoston Surgical Products, Inc.K950403SURGICAL SAW BLADESTransidyne General Corp.K940501RE-SHARPENABLE SAW BLADESAdven Medical

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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