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)

POWERFLEX PEC IMPLANT

K-Number: K973729 · 1997-12-24

ApplicantHanson Medical, Inc.
Decision Date1997-12-24
Product CodeMIC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

POWERFLEX PEC IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Hanson Medical, Inc.. It received FDA 510(k) clearance on 1997-12-24 under 510(k) number K973729. The device is classified under product code MIC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERFLEX PEC IMPLANT?

POWERFLEX PEC IMPLANT is a medical device that received FDA 510(k) clearance on 1997-12-24. The listed applicant is Hanson Medical, Inc.. The 510(k) number is K973729.

When did POWERFLEX PEC IMPLANT receive FDA 510(k) clearance?

POWERFLEX PEC IMPLANT received FDA 510(k) clearance on 1997-12-24, under 510(k) number K973729.

Who is the listed applicant for POWERFLEX PEC IMPLANT?

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

What is the FDA product code for POWERFLEX PEC IMPLANT?

The FDA product code for POWERFLEX PEC IMPLANT is MIC.

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 Hanson Medical, 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.

K090803HANSON MEDICAL FACIAL IMPLANTSK071018MONARCH NASAL IMPLANTK041690MONARCH NASAL IMPLANTK040307HANSON SCAR ADEK030808HANSON MEDICAL CALF IMPLANTK030809HANSON MEDICAL GLUTEAL IMPLANT

View all 13 devices →

Related Devices (Code: MIC)

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.

K021337AART PECTORALIS IMPLANTAesthetic and Reconstructive Technologies, Inc.K002633SILMAX PECTORAL IMPLANTPillar Surgical, Inc.K983043SEARE BIOMEDICAL SILICONE BLOCKSeare Biomedical Corp.K982762SEARE BIOMEDICAL PECTORALIS IMPLANTSeare Biomedical Corp.K961072PEC IMPLANTRand Scientific Corp.K944163SPECTRUM DISIGNS PECTORAL IMPLANTSpectrum Designs, 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.

↑