Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KARL STORZ DIRECT COUPLED CAMERA HEAD

K-Number: K973252 · 1997-11-24

ApplicantKarl Storz Imaging, Inc.
Decision Date1997-11-24
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ DIRECT COUPLED CAMERA HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Imaging, Inc.. It received FDA 510(k) clearance on 1997-11-24 under 510(k) number K973252. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ DIRECT COUPLED CAMERA HEAD?

KARL STORZ DIRECT COUPLED CAMERA HEAD is a medical device that received FDA 510(k) clearance on 1997-11-24. The listed applicant is Karl Storz Imaging, Inc.. The 510(k) number is K973252.

When did KARL STORZ DIRECT COUPLED CAMERA HEAD receive FDA 510(k) clearance?

KARL STORZ DIRECT COUPLED CAMERA HEAD received FDA 510(k) clearance on 1997-11-24, under 510(k) number K973252.

Who is the listed applicant for KARL STORZ DIRECT COUPLED CAMERA HEAD?

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

What is the FDA product code for KARL STORZ DIRECT COUPLED CAMERA HEAD?

The FDA product code for KARL STORZ DIRECT COUPLED CAMERA HEAD is FET.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Karl Storz Imaging, 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.

K003325KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEMK001362KARL STORZ 3D VIDEO SYSTEMK994090KARL STORZ AUTOCLAVABLE CAMERA HEADK990154KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEMK974391KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEMK963333OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)

View all 10 devices →

Related Devices (Code: FET)

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.

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology 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.

↑