Temporary Hemo Clip, 07-096-01/02 & Apply Forcep

FDA 510(k) K862696 · Downs Surgical , Ltd.

Substantially Equivalent

510(k) numberK862696

Submission

Device name
Temporary Hemo Clip, 07-096-01/02 & Apply Forcep
Applicant
Downs Surgical , Ltd.
Wilmington, MA, US
Received
July 15, 1986
Decision date
July 30, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HBT – Applier, Hemostatic Clip
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code HBT

510(k)DeviceApplicantDecision
K924929Reflex(R) EcaHBT · Traditional Richard-Allan Medical07/21/1993SE
K896262Titanium Ligating ClipsHBT · Traditional Richard-Allan Medical Ind., Inc.01/02/1990SE
K800318Doubletime 2-TIPPED Appliers for HemocliHBT · Traditional Edward Weck, Inc.03/10/1980SE

More from Edward Weck, Inc.

510(k)DeviceDecision
K903750Islam Sternal Puncture Needle, Cat #AG-598-OO-EGDM · Traditional 10/31/1990SE
K903749Islam Sternal Puncture Needle, Cat #AG-596-00-UGDM · Traditional 10/31/1990SE
K903748Islam Sternal Puncture Needle, Cat # AF-594-00-VGDM · Traditional 10/31/1990SE
K903747Islam Sternal Puncture Needle, Cat # AG-592-00-UGDM · Traditional 10/31/1990SE
K900616Shepperd Cutting ForcepsHRX · Traditional 10/22/1990SE
K900615Shepperd Nerve Root Retractor W/Suction & FibreHRX · Traditional 10/22/1990SE
K900614Shepperd Short Muscle Retractor (GS-501-45-V)HRX · Traditional 10/22/1990SE
K900613Shepperd Shelter Tube Complete & DrillHRX · Traditional 10/22/1990SE
K900612Shepperd Trephine Set (GS-501-30-V)HRX · Traditional 10/22/1990SE
K900611Shepperd Dilatation Tube Set (GS-501-20-H)HRX · Traditional 10/22/1990SE

Questions and answers

When was Temporary Hemo Clip, 07-096-01/02 & Apply Forcep cleared by the FDA?

Temporary Hemo Clip, 07-096-01/02 & Apply Forcep (K862696) received a 510(k) decision of Substantially Equivalent on July 30, 1986, 15 days after the submission was received.

What is the product code of K862696?

The FDA product code is HBT – Applier, Hemostatic Clip, a Class I (low risk) device regulated under 21 CFR 878.4800.