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)

TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE

K-Number: K010883 · 2001-04-06

ApplicantTeratech Corp.
Decision Date2001-04-06
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Teratech Corp.. It received FDA 510(k) clearance on 2001-04-06 under 510(k) number K010883. 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 TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE?

TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE is a medical device that received FDA 510(k) clearance on 2001-04-06. The listed applicant is Teratech Corp.. The 510(k) number is K010883.

When did TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE receive FDA 510(k) clearance?

TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE received FDA 510(k) clearance on 2001-04-06, under 510(k) number K010883.

Who is the listed applicant for TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE?

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

What is the FDA product code for TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE?

The FDA product code for TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE 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

Other records listing Teratech Corp. 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.

K131209TERASON USMART3200T ULTRASOUND SYSTEMK112953TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICSK110482PROSOUND C3 / C3 CV ULTRASOUND SYSTEMSK110020TERASON T3200 ULTRASOUND SYSTEMK080234TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHOK051334TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER

View all 12 devices →

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.

↑