Disposable Plastic Vaginal Specula

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K926536 ↗

FDA Product Code

HIB

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Endo Cervical Curette

  Class II

  FDA 510(k) K926532 Active Cleared 25 Feb 1994

• Micro Surgery Needle Holders

  Class II

  FDA 510(k) K930110 Active Cleared 24 Feb 1994

• Gomco Circumcision Clamp

  Class II

  FDA 510(k) K926535 Active Cleared 25 Feb 1994

• Roto Fit Biopsy Forceps

  Class I

  FDA 510(k) K926527 Active Cleared 25 Feb 1994

• Various Forceps

  Class II

  FDA 510(k) K930799 Active Cleared 24 Feb 1994

• Ovum Forceps

  Class II

  FDA 510(k) K926528 Active Cleared 24 Feb 1994

See all devices from Thomasville Medical Assoc. →

• What is the disposable plastic vaginal speculum used for?

  It is designed for single-use in obstetrics and gynecology examinations to visualize the vaginal canal and cervix during clinical procedures, allowing healthcare providers to conduct pelvic exams safely and effectively.

• How is the disposable plastic vaginal speculum supplied and is it reusable?

  The device is supplied sterile and intended for single-use only, meaning it should be discarded after one procedure to prevent cross-contamination and ensure patient safety.

• What regulatory clearance does the disposable plastic vaginal speculum have?

  It has received FDA 510(k) clearance (K926536) as substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device under FDA regulation number 884.4530.