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FDA 510(k)

BIPOLAR ENDOSTASIS PROBE, BEST (TM)

K-Number: K915408 · 1992-03-11

ApplicantMedical Devices, Inc.
Decision Date1992-03-11
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIPOLAR ENDOSTASIS PROBE, BEST (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 1992-03-11 under 510(k) number K915408. 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 BIPOLAR ENDOSTASIS PROBE, BEST (TM)?

BIPOLAR ENDOSTASIS PROBE, BEST (TM) is a medical device that received FDA 510(k) clearance on 1992-03-11. The listed applicant is Medical Devices, Inc.. The 510(k) number is K915408.

When did BIPOLAR ENDOSTASIS PROBE, BEST (TM) receive FDA 510(k) clearance?

BIPOLAR ENDOSTASIS PROBE, BEST (TM) received FDA 510(k) clearance on 1992-03-11, under 510(k) number K915408.

Who is the listed applicant for BIPOLAR ENDOSTASIS PROBE, BEST (TM)?

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

What is the FDA product code for BIPOLAR ENDOSTASIS PROBE, BEST (TM)?

The FDA product code for BIPOLAR ENDOSTASIS PROBE, BEST (TM) is KNS.

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Other records listing Medical Devices, Inc. as applicant

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K002280PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602K930084MICRO-ARTHROSCOPEK943126ELECTROFLEXK940012SMARTBRACE ELECTRODEK935132HOME MICROCURRENT HMCK934619FLEXMATE

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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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