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FDA 510(k)

ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME

K-Number: K934315 · 1994-02-28

ApplicantEndovations
Decision Date1994-02-28
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME is the device name listed in this FDA 510(k) record. The listed applicant is Endovations. It received FDA 510(k) clearance on 1994-02-28 under 510(k) number K934315. 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 ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME?

ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME is a medical device that received FDA 510(k) clearance on 1994-02-28. The listed applicant is Endovations. The 510(k) number is K934315.

When did ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME receive FDA 510(k) clearance?

ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME received FDA 510(k) clearance on 1994-02-28, under 510(k) number K934315.

Who is the listed applicant for ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME?

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

What is the FDA product code for ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME?

The FDA product code for ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME is KNS.

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Other records listing Endovations 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.

K955413ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETERK942110INJECT-SNAREK9138412 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATHK9138705MM MICROSCISSORSK911155OVAL CUP BIOPSY FORCEPK892218ENDO-SPONGE

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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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