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FDA 510(k)

SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM

K-Number: K910769 · 1991-06-25

ApplicantSurgitek Medical Engineering Corp.
Decision Date1991-06-25
Product CodeODD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek Medical Engineering Corp.. It received FDA 510(k) clearance on 1991-06-25 under 510(k) number K910769. 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 SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM?

SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM is a medical device that received FDA 510(k) clearance on 1991-06-25. The listed applicant is Surgitek Medical Engineering Corp.. The 510(k) number is K910769.

When did SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM receive FDA 510(k) clearance?

SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM received FDA 510(k) clearance on 1991-06-25, under 510(k) number K910769.

Who is the listed applicant for SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM?

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

What is the FDA product code for SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM?

The FDA product code for SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM is ODD.

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Other records listing Surgitek Medical Engineering 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.

K914504CYTOLOGY BRUSHK914495E.R.C.P. CATHETERK914497BIOPSY FORCEPSK914505STONE BASKETK914503GRASPING FORCEPSK914496SCLEROTHERAPY NEEDLE

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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

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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