Disposable Needle Holder
FDA 510(k) K831665 · Medcare Products
510(k) numberK831665
Submission
- Device name
- Disposable Needle Holder
- Applicant
- Medcare Products
Mchenry, IL, US - Received
- May 23, 1983
- Decision date
- September 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K943229 | Disposable Surgical Scissors and ForcepsKDC · Traditional | Y.M.K. International Co., Ltd. | 08/19/1994SE |
| K936226 | Surgimed Breast Localization Needle Wire SetKDC · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 03/07/1994SE |
| K920153 | Thermuff BagKDC · Traditional | Techstyles | 07/01/1992SE |
| K920263 | Manual Surgical InstrumentsKDC · Traditional | Phoenix Instruments Div. | 05/06/1992SE |
| K915064 | Disposable Cautery Abrasive PadKDC · Traditional | American Medical Mfg., Inc. | 03/11/1992SE |
| K914960 | Instrument OrganizerKDC · Traditional | O.R. Concepts, Inc. | 02/28/1992SE |
| K912834 | Shur-GripKDC · Traditional | Inman Medical Corp. | 07/26/1991SE |
| K910079 | Disposable Introducer SheathKDC · Traditional | Applied Vascular Devices, Inc. | 02/27/1991SE |
| K905240 | VesseloopsKDC · Traditional | Sparta Surgical Corp. | 02/06/1991SE |
| K903649 | Bradley Tenaculum HolderKDC · Traditional | Marlo Surgical Technology | 11/02/1990SE |
More from Marlo Surgical Technology
| 510(k) | Device | Decision |
|---|---|---|
| K841122 | Tracheostomy Care TrayFSM · Traditional | 04/25/1984SE |
| K841124 | Dialysis TrayKOC · Traditional | 04/20/1984SE |
| K841123 | Dressing Change TrayFRG · Traditional | 04/17/1984SE |
| K831374 | Med Care Prep Razor · Traditional | 10/04/1983SE |
| K831663 | Tissue ForcepsKOC · Traditional | 09/26/1983SE |
| K831664 | Plastic Thumb ForcepsKDC · Traditional | 09/12/1983SE |
| K831661 | Disposable ScissorsKDC · Traditional | 08/25/1983SE |
| K831662 | Disposable Hemostat (Straight&CurvedKDC · Traditional | 07/19/1983SE |
| K823854 | Medcare Suture Removal TraysFSM · Traditional | 03/31/1983SE |
| K823856 | Medcare General Purpose TrayFSM · Traditional | 01/14/1983SE |
Questions and answers
When was Disposable Needle Holder cleared by the FDA?
Disposable Needle Holder (K831665) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 112 days after the submission was received.
What is the product code of K831665?
The FDA product code is KDC – Instrument, Surgical, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.