CK 4900 Series, Gown and Towel Pak
FDA 510(k) K874760 · Currie Medical Specialties, Inc.
510(k) numberK874760
Submission
- Device name
- CK 4900 Series, Gown and Towel Pak
- Applicant
- Currie Medical Specialties, Inc.
Monrovia, CA, US - Received
- November 19, 1987
- Decision date
- December 10, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K213481 | Medline General Surgery TrayLRO · Traditional | Medline Industries, Inc. | 05/24/2022SE |
| K212258 | Medline Cardiovascular Procedure KitLRO · Traditional | Medline Industries, Inc. | 12/03/2021SE |
| K041080 | Surgical Drape Kit - D.I.R.R.A. SRLLRO · Traditional | D.I.R.R.A. S.R.L. | 11/30/2004SE |
| K030721 | Quick-Tap Paracentesis Tray, Kit & NeedleLRO · Special | Ballard Medical Products | 03/31/2003SE |
| K023276 | Amsino Tracheostomy Care TrayLRO · Traditional | Amsino International, Inc. | 12/09/2002SE |
| K980137 | Worldwide Medical Technologies Bone Marrow Biopsy Procedure TrayLRO · Traditional | Worldwide Medical Technologies, LLC | 01/30/1998SE |
| K971061 | Opportunity Inc. Bone Marrow Biopsy and Aspiration TrayLRO · Traditional | Opportunity, Inc. | 06/11/1997SN |
| K971062 | Opportunity Inc. General Purpose TrayLRO · Traditional | Opportunity, Inc. | 06/09/1997SN |
| K932221 | Neurological or Crani Trays (Packs)LRO · Traditional | Associated Medical Products Co. | 03/19/1997SE |
| K970286 | Presbyterian Linen Services Surgical PacksLRO · Traditional | Medline Industries, Inc. | 03/10/1997SE |
More from Medline Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K151158 | ALP VasQcare Take Home SystemJOW · Traditional | 12/10/2015SE |
| K143317 | Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)JOW · Traditional | 01/20/2015SE |
| K140092 | Currie Medical Reprocessed Alp Calf/Thigh/Foot Compression Sleeve (All Sizes)JOW · Traditional | 04/16/2014SE |
| K112311 | Alp 501 RB Pump SystemJOW · Special | 09/01/2011SE |
| K902441 | Disposable Procedural Trays #Ck-Xxxxx (Various)KDD · Traditional | 08/23/1990SEKD |
| K872395 | CK 1600 Series, TowelsKKX · Traditional | 07/02/1987SE |
| K871737 | CK 7000 Series 5 in 1 Connector and Y-ConnectorBZA · Traditional | 06/22/1987SE |
| K864816 | CK 5000 Series, Ace Bandage/Esmark Bandage · Traditional | 01/08/1987SE |
| K864697 | CK 6000 Series, TowelsKKX · Traditional | 12/18/1986SE |
| K834558 | CK10000 Series Pouch & Bags Etc.KCT · Traditional | 09/05/1984SE |
Questions and answers
When was CK 4900 Series, Gown and Towel Pak cleared by the FDA?
CK 4900 Series, Gown and Towel Pak (K874760) received a 510(k) decision of Substantially Equivalent on December 10, 1987, 21 days after the submission was received.
What is the product code of K874760?
The FDA product code is LRO – General Surgery Tray, a Class II (moderate risk) device regulated under 21 CFR 878.4370.