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)

PEERSCOPE SYSTEM

K-Number: K120289 · 2012-09-28

ApplicantPeermedical
Decision Date2012-09-28
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PEERSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Peermedical. It received FDA 510(k) clearance on 2012-09-28 under 510(k) number K120289. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEERSCOPE SYSTEM?

PEERSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-28. The listed applicant is Peermedical. The 510(k) number is K120289.

When did PEERSCOPE SYSTEM receive FDA 510(k) clearance?

PEERSCOPE SYSTEM received FDA 510(k) clearance on 2012-09-28, under 510(k) number K120289.

Who is the listed applicant for PEERSCOPE SYSTEM?

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

What is the FDA product code for PEERSCOPE SYSTEM?

The FDA product code for PEERSCOPE SYSTEM is FDF.

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: FDF)

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.

K260503Triton 1 SystemNeptune Medical, Inc.K261015Solo Scope Colonoscope SystemGi View, Ltd.K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLCK260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.

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.

↑