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FDA 510(k)

MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE

K-Number: K972926 · 1997-10-08

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1997-10-08
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MVM 7.5 FRENCH FLEXIBLE 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 1997-10-08 under 510(k) number K972926. 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 MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE?

MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE is a medical device that received FDA 510(k) clearance on 1997-10-08. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K972926.

When did MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE receive FDA 510(k) clearance?

MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE received FDA 510(k) clearance on 1997-10-08, under 510(k) number K972926.

Who is the listed applicant for MVM 7.5 FRENCH FLEXIBLE 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 MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE?

The FDA product code for MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE is FBN.

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Other records listing KARL STORZ Endoscopy-America, 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.

K252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH 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 SystemK223923HOPKINS Telescopes

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Related Devices (Code: FBN)

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.

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, LLCK243535Flexible 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.

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