Simpex Inc. Surgical Dressing

FDA 510(k) K913794 · Simpex, Inc.

Substantially Equivalent

510(k) numberK913794

Submission

Device name
Simpex Inc. Surgical Dressing
Applicant
Simpex, Inc.
Jenkintown, PA, US
Received
August 23, 1991
Decision date
November 20, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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

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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
K920174Easy Touch Latex Eam GlovesLYY · Traditional 04/22/1992SE
K913793Simpex Inc. Oral and Rectal ThermometersFLK · Traditional 12/30/1991SE
K911505Fixation WireHTY · Traditional 04/12/1991SE
K911452Fixation PinHTY · Traditional 04/12/1991SE

Questions and answers

When was Simpex Inc. Surgical Dressing cleared by the FDA?

Simpex Inc. Surgical Dressing (K913794) received a 510(k) decision of Substantially Equivalent on November 20, 1991, 89 days after the submission was received.

What is the product code of K913794?

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