FDA 510(k)

DISPOSABLE PLASTIC VAGINAL SPECULA

K-Number: K926536 · 1994-02-25

Decision Date1994-02-25

Product CodeHIB

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE PLASTIC VAGINAL SPECULA is the device name listed in this FDA 510(k) record. The listed applicant is Thomasville Medical Assoc.. It received FDA 510(k) clearance on 1994-02-25 under 510(k) number K926536. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE PLASTIC VAGINAL SPECULA?

DISPOSABLE PLASTIC VAGINAL SPECULA is a medical device that received FDA 510(k) clearance on 1994-02-25. The listed applicant is Thomasville Medical Assoc.. The 510(k) number is K926536.

When did DISPOSABLE PLASTIC VAGINAL SPECULA receive FDA 510(k) clearance?

DISPOSABLE PLASTIC VAGINAL SPECULA received FDA 510(k) clearance on 1994-02-25, under 510(k) number K926536.

Who is the listed applicant for DISPOSABLE PLASTIC VAGINAL SPECULA?

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

What is the FDA product code for DISPOSABLE PLASTIC VAGINAL SPECULA?

The FDA product code for DISPOSABLE PLASTIC VAGINAL SPECULA is HIB.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Thomasville Medical Assoc. as applicant

K926429VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT K926471MOGAN CIRCUMCISION CLAMP K926527ROTO FIT BIOPSY FORCEPS K926535GOMCO CIRCUMCISION CLAMP K926532ENDO CERVICAL CURETTE K926531HYSTERECTOMY FORCEPS

View all 33 devices →

Related Devices (Code: HIB)

K252208JFord Speculum Sleeve™Ford Medtech, LLC K130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLC K120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI Ltda K092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation

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.