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)

TRANS VAGINAL NEEDLE GUIDE

K-Number: K971722 · 1997-07-10

ApplicantProtek Medical Products, Inc.
Decision Date1997-07-10
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRANS VAGINAL NEEDLE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Protek Medical Products, Inc.. It received FDA 510(k) clearance on 1997-07-10 under 510(k) number K971722. 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 TRANS VAGINAL NEEDLE GUIDE?

TRANS VAGINAL NEEDLE GUIDE is a medical device that received FDA 510(k) clearance on 1997-07-10. The listed applicant is Protek Medical Products, Inc.. The 510(k) number is K971722.

When did TRANS VAGINAL NEEDLE GUIDE receive FDA 510(k) clearance?

TRANS VAGINAL NEEDLE GUIDE received FDA 510(k) clearance on 1997-07-10, under 510(k) number K971722.

Who is the listed applicant for TRANS VAGINAL NEEDLE GUIDE?

The FDA 510(k) record lists Protek Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANS VAGINAL NEEDLE GUIDE?

The FDA product code for TRANS VAGINAL NEEDLE GUIDE 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 Protek Medical Products, 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.

K973958GENERAL PURPOSE ATL NEEDLE GUIDE KITK973622TRANSDUCER POSITIONERK970893ULTRASOUND TRANSDUCER DRAPEK970889ULTRASOUND TRANSDUCER DRAPEK973362NEEDLE GUIDE/GRIDK970885ULTRASOUND SYSTEMS DRAPE

View all 9 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.

↑