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)

SUNLITE LARYNGOSCOPE

K-Number: K921263 · 1993-06-01

ApplicantSunmed, Inc.
Decision Date1993-06-01
Product CodeCCW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SUNLITE LARYNGOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Sunmed, Inc.. It received FDA 510(k) clearance on 1993-06-01 under 510(k) number K921263. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNLITE LARYNGOSCOPE?

SUNLITE LARYNGOSCOPE is a medical device that received FDA 510(k) clearance on 1993-06-01. The listed applicant is Sunmed, Inc.. The 510(k) number is K921263.

When did SUNLITE LARYNGOSCOPE receive FDA 510(k) clearance?

SUNLITE LARYNGOSCOPE received FDA 510(k) clearance on 1993-06-01, under 510(k) number K921263.

Who is the listed applicant for SUNLITE LARYNGOSCOPE?

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

What is the FDA product code for SUNLITE LARYNGOSCOPE?

The FDA product code for SUNLITE LARYNGOSCOPE is CCW.

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 Sunmed, 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.

K062112SUNMED FOLEY CATHETERSK955631ORTHOPLUG HARD BONE DESIGNK955632ORTHOPLUG SOFT BONE DESIGN

Related Devices (Code: CCW)

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.

K191602APA Oxy BladeVenner Medical (Singapore) Pte, Ltd.K163412Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)Girgis Scope, LLCK121378AIRTRAQ SP AIRTRAQ AVANTProdol Meditec , Ltd.K063477NOVAMED MRI CONDITIONAL LARYNGOSCOPE SETNovamed, LLCK062523TRU-MR LARYNGOSCOPE SETTruphatek International, Ltd.K062230MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002Minrad, 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.

↑