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)

SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600

K-Number: K990253 · 1999-09-24

ApplicantAmba Medical , Ltd.
Decision Date1999-09-24
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600 is the device name listed in this FDA 510(k) record. The listed applicant is Amba Medical , Ltd.. It received FDA 510(k) clearance on 1999-09-24 under 510(k) number K990253. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600?

SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600 is a medical device that received FDA 510(k) clearance on 1999-09-24. The listed applicant is Amba Medical , Ltd.. The 510(k) number is K990253.

When did SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600 receive FDA 510(k) clearance?

SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600 received FDA 510(k) clearance on 1999-09-24, under 510(k) number K990253.

Who is the listed applicant for SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600?

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

What is the FDA product code for SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600?

The FDA product code for SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600 is KKX.

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: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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.

↑