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)

TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM

K-Number: K963505 · 1997-02-14

ApplicantTenet Medical Engineering
Decision Date1997-02-14
Product CodeHHP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tenet Medical Engineering. It received FDA 510(k) clearance on 1997-02-14 under 510(k) number K963505. The device is classified under product code HHP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM?

TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-14. The listed applicant is Tenet Medical Engineering. The 510(k) number is K963505.

When did TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM receive FDA 510(k) clearance?

TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM received FDA 510(k) clearance on 1997-02-14, under 510(k) number K963505.

Who is the listed applicant for TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM?

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

What is the FDA product code for TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM?

The FDA product code for TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM is HHP.

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 Tenet Medical Engineering 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.

K963506TENET RADIOLUCENT HAND TABLEK964102TENET TIBIAL FRACTURE SUPPORT

Related Devices (Code: HHP)

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.

K822812YSI MODEL 23L LACTATE ANALYZERYellow Springs Instrument Co., 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.

↑