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FDA 510(k)

BITOME(TM) BIPOLAR SPHINCTEROTOME

K-Number: K895842 · 1990-01-11

ApplicantEverest Medical Corp.
Decision Date1990-01-11
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BITOME(TM) BIPOLAR SPHINCTEROTOME is the device name listed in this FDA 510(k) record. The listed applicant is Everest Medical Corp.. It received FDA 510(k) clearance on 1990-01-11 under 510(k) number K895842. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BITOME(TM) BIPOLAR SPHINCTEROTOME?

BITOME(TM) BIPOLAR SPHINCTEROTOME is a medical device that received FDA 510(k) clearance on 1990-01-11. The listed applicant is Everest Medical Corp.. The 510(k) number is K895842.

When did BITOME(TM) BIPOLAR SPHINCTEROTOME receive FDA 510(k) clearance?

BITOME(TM) BIPOLAR SPHINCTEROTOME received FDA 510(k) clearance on 1990-01-11, under 510(k) number K895842.

Who is the listed applicant for BITOME(TM) BIPOLAR SPHINCTEROTOME?

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

What is the FDA product code for BITOME(TM) BIPOLAR SPHINCTEROTOME?

The FDA product code for BITOME(TM) BIPOLAR SPHINCTEROTOME is KNS.

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Other records listing Everest Medical 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.

K003060PLASMAKINETIC GENERATORK000496EVERSHEARS BIPOLAR SCISSORSK993412BITX PROBESK994336BITX PROBESK971565BICOAG COAGULATING FORCEPSK955001EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS

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Related Devices (Code: KNS)

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.

K262460Rezum SystemBoston ScientificK260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems CorporationK250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

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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