FDA 510(k)

11274 AC FLEXINBLE CHOLEDOCHOSCOPE

K-Number: K931382 · 1993-06-18

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1993-06-18

Product CodeFBN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

11274 AC FLEXINBLE CHOLEDOCHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1993-06-18 under 510(k) number K931382. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 11274 AC FLEXINBLE CHOLEDOCHOSCOPE?

11274 AC FLEXINBLE CHOLEDOCHOSCOPE is a medical device that received FDA 510(k) clearance on 1993-06-18. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K931382.

When did 11274 AC FLEXINBLE CHOLEDOCHOSCOPE receive FDA 510(k) clearance?

11274 AC FLEXINBLE CHOLEDOCHOSCOPE received FDA 510(k) clearance on 1993-06-18, under 510(k) number K931382.

Who is the listed applicant for 11274 AC FLEXINBLE CHOLEDOCHOSCOPE?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 11274 AC FLEXINBLE CHOLEDOCHOSCOPE?

The FDA product code for 11274 AC FLEXINBLE CHOLEDOCHOSCOPE is FBN.

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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

K252624KARL STORZ Laryngoscopes and Accessories K240506KARL STORZ Holders K223885HOPKINS Telescopes K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII System K223923HOPKINS Telescopes

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Related Devices (Code: FBN)

K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.K253139Disposable Distal CapMirco-Tech (Nanjing) Co., Ltd.K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)Scivita Medical Technology Co., Ltd.K251170Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital ControllerTangent Endoscopy, LLC K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)Shanghai SeeGen Photoelectric Technology Co., Ltd.K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.

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.