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)

SPECULITE DISPOSABLE VAGINAL LIGHT

K-Number: K853257 · 1985-12-27

ApplicantTrylon Associates, Ltd.
Decision Date1985-12-27
Product CodeHIC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPECULITE DISPOSABLE VAGINAL LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Trylon Associates, Ltd.. It received FDA 510(k) clearance on 1985-12-27 under 510(k) number K853257. The device is classified under product code HIC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECULITE DISPOSABLE VAGINAL LIGHT?

SPECULITE DISPOSABLE VAGINAL LIGHT is a medical device that received FDA 510(k) clearance on 1985-12-27. The listed applicant is Trylon Associates, Ltd.. The 510(k) number is K853257.

When did SPECULITE DISPOSABLE VAGINAL LIGHT receive FDA 510(k) clearance?

SPECULITE DISPOSABLE VAGINAL LIGHT received FDA 510(k) clearance on 1985-12-27, under 510(k) number K853257.

Who is the listed applicant for SPECULITE DISPOSABLE VAGINAL LIGHT?

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

What is the FDA product code for SPECULITE DISPOSABLE VAGINAL LIGHT?

The FDA product code for SPECULITE DISPOSABLE VAGINAL LIGHT is HIC.

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: HIC)

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.

K955790PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAYTrylon Corp.K923656LIGHTING SOURCE SYSTEMGalenica Enterprises, Inc.K902516NEW LENGTH SUGITA APPLIERSSims Surgical, Inc.K897100CENTURION VAGINAL SPECULUMTri-State Hospital Supply Corp.

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.

↑