Vesseloops

FDA 510(k) K905240 · Sparta Surgical Corp.

Substantially Equivalent

510(k) numberK905240

Submission

Device name
Vesseloops
Applicant
Sparta Surgical Corp.
Hammonton, NJ, US
Received
November 20, 1990
Decision date
February 6, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KDC – Instrument, Surgical, Disposable
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code KDC

510(k)DeviceApplicantDecision
K943229Disposable Surgical Scissors and ForcepsKDC · Traditional Y.M.K. International Co., Ltd.08/19/1994SE
K936226Surgimed Breast Localization Needle Wire SetKDC · Traditional Meadox Medicals, Div. Boston Scientific Corp.03/07/1994SE
K920153Thermuff BagKDC · Traditional Techstyles07/01/1992SE
K920263Manual Surgical InstrumentsKDC · Traditional Phoenix Instruments Div.05/06/1992SE
K915064Disposable Cautery Abrasive PadKDC · Traditional American Medical Mfg., Inc.03/11/1992SE
K914960Instrument OrganizerKDC · Traditional O.R. Concepts, Inc.02/28/1992SE
K912834Shur-GripKDC · Traditional Inman Medical Corp.07/26/1991SE
K910079Disposable Introducer SheathKDC · Traditional Applied Vascular Devices, Inc.02/27/1991SE
K903649Bradley Tenaculum HolderKDC · Traditional Marlo Surgical Technology11/02/1990SE
K900566Richard-Allan Vessel LoopsKDC · Traditional Richard-Allan Medical Ind., Inc.05/03/1990SE

More from Richard-Allan Medical Ind., Inc.

510(k)DeviceDecision
K965187Spectrum II, Spectrum Plus, and Spectrum Max-SdGZJ · Traditional 08/01/1997SE
K945313Sparta Hydrogel Wound DressingMGQ · Traditional 01/12/1995SE
K922729Sparta Wet Dressing, Sodium ChlorideFRO · Traditional 11/23/1992SN
K905384David Simmonds Anesthesia Extension TubesFMF · Traditional 03/22/1991SE
K896085Surgi-BrushGEC · Traditional 11/08/1989SE
K896084MicrospearsHOZ · Traditional 11/02/1989SE

Questions and answers

When was Vesseloops cleared by the FDA?

Vesseloops (K905240) received a 510(k) decision of Substantially Equivalent on February 6, 1991, 78 days after the submission was received.

What is the product code of K905240?

The FDA product code is KDC – Instrument, Surgical, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.