Searle Vascular Loops
FDA 510(k) K802485 · G.D. Searle and Co.
510(k) numberK802485
Submission
- Device name
- Searle Vascular Loops
- Applicant
- G.D. Searle and Co.
Mchenry, IL, US - Received
- October 10, 1980
- Decision date
- February 12, 1981
- 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 |
|---|---|---|
| K821159 | In-Line Oxygen Monitoring SystemDRY · Traditional | 05/25/1982SE |
| K811068 | Bypass CoilKPY · Traditional | 05/27/1981SE |
| K811071 | Venous Oxygen ProbeCCE · Traditional | 05/05/1981SE |
| K803238 | Intravascular CatheterFOZ · Traditional | 04/23/1981SE |
| K810630 | Silicone Elastomer Coated Latex FoleyKOD · Traditional | 03/31/1981SE |
| K810131 | Administration SetFPD · Traditional | 02/26/1981SE |
| K801805 | Metronidazole DiscsJWY · Traditional | 02/10/1981SE |
| K810112 | SWR Disposable Prep RazorKDC · Traditional | 02/04/1981SE |
| K802280 | White Knight Drape SealKKX · Traditional | 10/10/1980SE |
| K802213 | White Knight Bovie Cord/Suction TubeKKX · Traditional | 10/10/1980SE |
Questions and answers
When was Searle Vascular Loops cleared by the FDA?
Searle Vascular Loops (K802485) received a 510(k) decision of Substantially Equivalent on February 12, 1981, 125 days after the submission was received.
What is the product code of K802485?
The FDA product code is KDC – Instrument, Surgical, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.