Richard-Allan Vessel Loops
FDA 510(k) K900566 · Richard-Allan Medical Ind., Inc.
510(k) numberK900566
Submission
- Device name
- Richard-Allan Vessel Loops
- Applicant
- Richard-Allan Medical Ind., Inc.
Richland, MI, US - Received
- February 7, 1990
- Decision date
- May 3, 1990
- 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
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| 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 |
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| K896262 | Titanium Ligating ClipsHBT · Traditional | 01/02/1990SE |
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| K862404 | Reflex(Tm) Clip ApplierFZP · Traditional | 07/23/1986SE |
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Questions and answers
When was Richard-Allan Vessel Loops cleared by the FDA?
Richard-Allan Vessel Loops (K900566) received a 510(k) decision of Substantially Equivalent on May 3, 1990, 85 days after the submission was received.
What is the product code of K900566?
The FDA product code is KDC – Instrument, Surgical, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.