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)

SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A

K-Number: K925434 · 1993-09-30

ApplicantKretz Technik
Decision Date1993-09-30
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A is the device name listed in this FDA 510(k) record. The listed applicant is Kretz Technik. It received FDA 510(k) clearance on 1993-09-30 under 510(k) number K925434. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A?

SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A is a medical device that received FDA 510(k) clearance on 1993-09-30. The listed applicant is Kretz Technik. The 510(k) number is K925434.

When did SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A receive FDA 510(k) clearance?

SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A received FDA 510(k) clearance on 1993-09-30, under 510(k) number K925434.

Who is the listed applicant for SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A?

The FDA 510(k) record lists Kretz Technik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A?

The FDA product code for SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A is ITX.

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

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

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.

↑