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FDA 510(k)

KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE

K-Number: K971977 · 1997-08-12

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1997-08-12
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE 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 1997-08-12 under 510(k) number K971977. 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 KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE?

KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE is a medical device that received FDA 510(k) clearance on 1997-08-12. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K971977.

When did KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE receive FDA 510(k) clearance?

KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE received FDA 510(k) clearance on 1997-08-12, under 510(k) number K971977.

Who is the listed applicant for KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE?

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 KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE?

The FDA product code for KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE 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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