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FDA 510(k)

PORGES SPHINCTEROTOMES

K-Number: K896426 · 1990-01-22

ApplicantPorges Corp.
Decision Date1990-01-22
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PORGES SPHINCTEROTOMES is the device name listed in this FDA 510(k) record. The listed applicant is Porges Corp.. It received FDA 510(k) clearance on 1990-01-22 under 510(k) number K896426. 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 PORGES SPHINCTEROTOMES?

PORGES SPHINCTEROTOMES is a medical device that received FDA 510(k) clearance on 1990-01-22. The listed applicant is Porges Corp.. The 510(k) number is K896426.

When did PORGES SPHINCTEROTOMES receive FDA 510(k) clearance?

PORGES SPHINCTEROTOMES received FDA 510(k) clearance on 1990-01-22, under 510(k) number K896426.

Who is the listed applicant for PORGES SPHINCTEROTOMES?

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

What is the FDA product code for PORGES SPHINCTEROTOMES?

The FDA product code for PORGES SPHINCTEROTOMES is KNS.

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Other records listing Porges 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.

K900269PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGEK900031MODIFIED PEDIATRIC SILICONE FOLEY CATHETERSK896505PORGES UNIVERSAL HANDLESK896503PORGES ERCP CATHETERSK896425PORGES CYTOLOGY BRUSHESK896507PORGES DIATHERMY SNARE

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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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