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FDA 510(k)

AMERICAN CATHETER SPHINCTEROTOME

K-Number: K942068 · 1994-06-24

ApplicantIntl. Medical, Inc.
Decision Date1994-06-24
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMERICAN CATHETER SPHINCTEROTOME is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical, Inc.. It received FDA 510(k) clearance on 1994-06-24 under 510(k) number K942068. 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 AMERICAN CATHETER SPHINCTEROTOME?

AMERICAN CATHETER SPHINCTEROTOME is a medical device that received FDA 510(k) clearance on 1994-06-24. The listed applicant is Intl. Medical, Inc.. The 510(k) number is K942068.

When did AMERICAN CATHETER SPHINCTEROTOME receive FDA 510(k) clearance?

AMERICAN CATHETER SPHINCTEROTOME received FDA 510(k) clearance on 1994-06-24, under 510(k) number K942068.

Who is the listed applicant for AMERICAN CATHETER SPHINCTEROTOME?

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

What is the FDA product code for AMERICAN CATHETER SPHINCTEROTOME?

The FDA product code for AMERICAN CATHETER SPHINCTEROTOME is KNS.

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Other records listing Intl. Medical, 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.

K970507PEAK FLOW METERK943078HOT BIOPSY FORCEPSK940370AMERICAN CATHETER E.R.C.P. CANNULAK940335AMERICAN CATHETER POLY-SNAREK930410DURHAM; LUER LOCK EXTENSION SETK930406DURHAM; MIN BORE LUER LOCK EXTENSION SET

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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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