Pre-Pack TENS

FDA 510(k) K813286 · Cunningham Woodland, Inc.

Substantially Equivalent

510(k) numberK813286

Submission

Device name
Pre-Pack TENS
Applicant
Cunningham Woodland, Inc.
Mchenry, IL, US
Received
November 23, 1981
Decision date
January 22, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GDY – Gauze/Sponge, Internal, X-Ray Detectable
Device class
Class I (low risk)
Regulation
21 CFR 878.4450
Specialty
General, Plastic Surgery

Other 510(k)s with product code GDY

510(k)DeviceApplicantDecision
K972634Ultracell Suction SpongeGDY · Traditional Ultracell Medical Technologies, Inc.12/17/1997SE
K960236CPR Lap SpongesGDY · Traditional Custom Pack Reliability03/28/1996SE
K955599Stryker Femoral Canal Sponge & Acetabulum SpongeGDY · Traditional Stryker Corp.02/22/1996SE
K955322Protec X-Ray Detectable Gauze SpongeGDY · Traditional Derivados DE Gasa, S.A. DE C.V.12/19/1995SE
K953830KensorbGDY · Traditional Kentron Health Care, Inc.10/03/1995SE
K953088Triangular SpongesGDY · Traditional Medical Perspectives Corp.09/14/1995SE
K953087Cherry Pit DissectorGDY · Traditional Medical Perspectives Corp.09/14/1995SE
K953062Cherry DissectorGDY · Traditional Medical Perspectives Corp.09/14/1995SE
K953060Rosebud DissectorGDY · Traditional Medical Perspectives Corp.09/14/1995SE
K953059Kittner DissectorGDY · Traditional Medical Perspectives Corp.09/14/1995SE

More from Medical Perspectives Corp.

510(k)DeviceDecision
K823527Subclavian Insertion KitFMF · Traditional 03/31/1983SE
K813519Non-Absorbent TowelsKME · Traditional 01/05/1982SE
K813284Venous Cannula TrayDWS · Traditional 12/29/1981SE
K811091Minor Dressing TrayLDQ · Traditional 05/08/1981SE
K811090Major Dressing TrayLDQ · Traditional 05/08/1981SE
K811089One Step Prep KitLDQ · Traditional 05/08/1981SE
K811088Dressing Tray Mercy HospitalLDQ · Traditional 05/08/1981SE
K811087Mika Skin Scrub Tray Pre Operative W/GelFSM · Traditional 05/01/1981SE
K811086Suture Removal Set(Displsable)KDD · Traditional 05/01/1981SE

Questions and answers

When was Pre-Pack TENS cleared by the FDA?

Pre-Pack TENS (K813286) received a 510(k) decision of Substantially Equivalent on January 22, 1982, 60 days after the submission was received.

What is the product code of K813286?

The FDA product code is GDY – Gauze/Sponge, Internal, X-Ray Detectable, a Class I (low risk) device regulated under 21 CFR 878.4450.