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FDA 510(k)

ENDOSCOPIC CATHETER

K-Number: K953967 · 1996-01-22

ApplicantAct Medical, Inc.
Decision Date1996-01-22
Product CodeODD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Act Medical, Inc.. It received FDA 510(k) clearance on 1996-01-22 under 510(k) number K953967. The device is classified under product code ODD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC CATHETER?

ENDOSCOPIC CATHETER is a medical device that received FDA 510(k) clearance on 1996-01-22. The listed applicant is Act Medical, Inc.. The 510(k) number is K953967.

When did ENDOSCOPIC CATHETER receive FDA 510(k) clearance?

ENDOSCOPIC CATHETER received FDA 510(k) clearance on 1996-01-22, under 510(k) number K953967.

Who is the listed applicant for ENDOSCOPIC CATHETER?

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

What is the FDA product code for ENDOSCOPIC CATHETER?

The FDA product code for ENDOSCOPIC CATHETER is ODD.

Related Clinical Trials

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.

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Other records listing Act 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.

K990693FLEXNEEDLE PLUS

Related Devices (Code: ODD)

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.

K250573Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614MOlympus Medical Systems Corp.K202583BioShield biopsy valve EUS - LinearSTERIS CorporationK171989Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal CatheterWilson-Cook Medical, Inc.K070420BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138United States Endoscopy Group, Inc.K011149DISPOSABLE BENDING CANNULA PR-233QThe Olympus Optical Co.K010993ALIEN RX MICRO CANNULA, MODEL 4530Boston Scientific Corp

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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