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FDA 510(k)

ENDODYNAMIC SIEGEL SPHINCTEROTOME

K-Number: K853680 · 1985-11-04

ApplicantE-Z-Em, Inc.
Decision Date1985-11-04
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDODYNAMIC SIEGEL SPHINCTEROTOME is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1985-11-04 under 510(k) number K853680. 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 ENDODYNAMIC SIEGEL SPHINCTEROTOME?

ENDODYNAMIC SIEGEL SPHINCTEROTOME is a medical device that received FDA 510(k) clearance on 1985-11-04. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K853680.

When did ENDODYNAMIC SIEGEL SPHINCTEROTOME receive FDA 510(k) clearance?

ENDODYNAMIC SIEGEL SPHINCTEROTOME received FDA 510(k) clearance on 1985-11-04, under 510(k) number K853680.

Who is the listed applicant for ENDODYNAMIC SIEGEL SPHINCTEROTOME?

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

What is the FDA product code for ENDODYNAMIC SIEGEL SPHINCTEROTOME?

The FDA product code for ENDODYNAMIC SIEGEL SPHINCTEROTOME is KNS.

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Other records listing E-Z-Em, 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.

K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESK062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900K053008E-Z-EM ENDOSCOPIC CO2 REGULATORK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

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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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