Port Access Kits

FDA 510(k) K872011 · The Jarid Group, Inc.

Substantially Equivalent

510(k) numberK872011

Submission

Device name
Port Access Kits
Applicant
The Jarid Group, Inc.
Wayside, NJ, US
Received
May 26, 1987
Decision date
July 13, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LRO – General Surgery Tray
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4370
Specialty
General, Plastic Surgery

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

Other 510(k)s with product code LRO

510(k)DeviceApplicantDecision
K213481Medline General Surgery TrayLRO · Traditional Medline Industries, Inc.05/24/2022SE
K212258Medline Cardiovascular Procedure KitLRO · Traditional Medline Industries, Inc.12/03/2021SE
K041080Surgical Drape Kit - D.I.R.R.A. SRLLRO · Traditional D.I.R.R.A. S.R.L.11/30/2004SE
K030721Quick-Tap Paracentesis Tray, Kit & NeedleLRO · Special Ballard Medical Products03/31/2003SE
K023276Amsino Tracheostomy Care TrayLRO · Traditional Amsino International, Inc.12/09/2002SE
K980137Worldwide Medical Technologies Bone Marrow Biopsy Procedure TrayLRO · Traditional Worldwide Medical Technologies, LLC01/30/1998SE
K971061Opportunity Inc. Bone Marrow Biopsy and Aspiration TrayLRO · Traditional Opportunity, Inc.06/11/1997SN
K971062Opportunity Inc. General Purpose TrayLRO · Traditional Opportunity, Inc.06/09/1997SN
K932221Neurological or Crani Trays (Packs)LRO · Traditional Associated Medical Products Co.03/19/1997SE
K970286Presbyterian Linen Services Surgical PacksLRO · Traditional Medline Industries, Inc.03/10/1997SE

More from Medline Industries, Inc.

510(k)DeviceDecision
K871322Advanced Medical Systems, KitLRO · Traditional 05/27/1987SE
K871281IV Start KitLRS · Traditional 05/27/1987SE

Questions and answers

When was Port Access Kits cleared by the FDA?

Port Access Kits (K872011) received a 510(k) decision of Substantially Equivalent on July 13, 1987, 48 days after the submission was received.

What is the product code of K872011?

The FDA product code is LRO – General Surgery Tray, a Class II (moderate risk) device regulated under 21 CFR 878.4370.