Tissue Forceps
FDA 510(k) K831663 · Medcare Products
510(k) numberK831663
Submission
- Device name
- Tissue Forceps
- Applicant
- Medcare Products
Mchenry, IL, US - Received
- May 23, 1983
- Decision date
- September 26, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOC – Accessories, Blood Circuit, Hemodialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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|---|---|---|---|
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | Nikkiso Co., Ltd. | 05/15/2025SE |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | Nikkiso Co., Ltd. | 05/15/2025SE |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-EKOC · Traditional | Nikkiso Co., Ltd. | 07/28/2023SE |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for…KOC · Traditional | Nikkiso Co., Ltd. | 06/16/2023SE |
| K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated…KOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 09/18/2020SE |
| K172238 | CAREline Airless Hemodialysis Blood Tubing SetsKOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 12/14/2017SE |
| K160749 | CRIT-LINE III Blood Chamber IIKOC · Special | Fresenius Medical Care Renal Therapies Group, LLC | 04/15/2016SE |
| K152953 | Crit-Line Clip (Clic) Blood ChamberKOC · Special | Fresenius Medical Care North America | 11/05/2015SE |
| K141997 | Crit-Line IV SystemKOC · Traditional | Fresenius Medical Care | 04/01/2015SE |
| K141281 | Crit-Line Clip (Clic) Blood ChamberKOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 08/14/2014SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 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 |
| K831665 | Disposable Needle HolderKDC · Traditional | 09/12/1983SE |
| 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 Tissue Forceps cleared by the FDA?
Tissue Forceps (K831663) received a 510(k) decision of Substantially Equivalent on September 26, 1983, 126 days after the submission was received.
What is the product code of K831663?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.