Endo-Needle Instrument

FDA 510(k) K936207 · Gerard Medical, Inc.

Substantially Equivalent

510(k) numberK936207

Submission

Device name
Endo-Needle Instrument
Applicant
Gerard Medical, Inc.
Charlton, MA, US
Received
December 29, 1993
Decision date
June 16, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GDM – Needle, Aspiration And Injection, Reusable
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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K953082Iliac Crest Bone Marrow Aspiration NeedleGDM · Traditional Baxter Healthcare Corp09/22/1995SE
K953064Bioaccess Marrow Harvest SystemGDM · Traditional Bioaccess, Inc.08/07/1995SE
K930160Illinois Sternal/Iliac Aspiration NeedleGDM · Traditional Symbiosis Corp.07/06/1993SE
K923872Bone Marrow Biopsy SystemGDM · Traditional The Straumann Co.12/15/1992SE
K915572Becton Dickinson Modified Menghini NeedleGDM · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic02/03/1992SE
K904667Na NeedlesGDM · Traditional Olympus Corp.12/12/1990SE
K903750Islam Sternal Puncture Needle, Cat #AG-598-OO-EGDM · Traditional Downs Surgical , Ltd.10/31/1990SE
K903749Islam Sternal Puncture Needle, Cat #AG-596-00-UGDM · Traditional Downs Surgical , Ltd.10/31/1990SE

More from Downs Surgical , Ltd.

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K974533TrimportLJT · Traditional 05/07/1998SE
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Questions and answers

When was Endo-Needle Instrument cleared by the FDA?

Endo-Needle Instrument (K936207) received a 510(k) decision of Substantially Equivalent on June 16, 1994, 169 days after the submission was received.

What is the product code of K936207?

The FDA product code is GDM – Needle, Aspiration And Injection, Reusable, a Class I (low risk) device regulated under 21 CFR 878.4800.