Tonsil Sponge, Gauze Dissector, Cylindrical Sponges

FDA 510(k) K940903 · Medical Insights, Inc.

Substantially Equivalent

510(k) numberK940903

Submission

Device name
Tonsil Sponge, Gauze Dissector, Cylindrical Sponges
Applicant
Medical Insights, Inc.
Mystic, CT, US
Received
February 24, 1994
Decision date
April 14, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KBM – Dissector, Tonsil
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Specialty
Ear, Nose, Throat

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K924958Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep TrayKDD · Traditional 06/07/1993SEKD

Questions and answers

When was Tonsil Sponge, Gauze Dissector, Cylindrical Sponges cleared by the FDA?

Tonsil Sponge, Gauze Dissector, Cylindrical Sponges (K940903) received a 510(k) decision of Substantially Equivalent on April 14, 1994, 49 days after the submission was received.

What is the product code of K940903?

The FDA product code is KBM – Dissector, Tonsil, a Class I (low risk) device regulated under 21 CFR 874.4420.