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FDA 510(k)

STERILE DISPOSABLE KNIFE

K-Number: K790259 · 1979-02-13

ApplicantIntermedics, Inc.
Decision Date1979-02-13
Product CodeGDX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE DISPOSABLE KNIFE is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1979-02-13 under 510(k) number K790259. The device is classified under product code GDX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE DISPOSABLE KNIFE?

STERILE DISPOSABLE KNIFE is a medical device that received FDA 510(k) clearance on 1979-02-13. The listed applicant is Intermedics, Inc.. The 510(k) number is K790259.

When did STERILE DISPOSABLE KNIFE receive FDA 510(k) clearance?

STERILE DISPOSABLE KNIFE received FDA 510(k) clearance on 1979-02-13, under 510(k) number K790259.

Who is the listed applicant for STERILE DISPOSABLE KNIFE?

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

What is the FDA product code for STERILE DISPOSABLE KNIFE?

The FDA product code for STERILE DISPOSABLE KNIFE is GDX.

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Other records listing Intermedics, 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

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Related Devices (Code: GDX)

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.

K923689SURGISTAR BLADESSurgistar, Inc.K921167ULTRABLADEMicron Technology, Inc.K914086ICAN CYLINDRICAL SPONGESIcn Pharmaceuticals, Inc.K904505CCI CORNEAL SCARIFIERBuckman Co., Inc.K9053801-CUT ACL GRAFT KNIFEDepuy, Inc.K895682VESSEL LOOPSApplied Medical Technologies

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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