SDC Vascular Ties
FDA 510(k) K833355 · Science Development Corp.
510(k) numberK833355
Submission
- Device name
- SDC Vascular Ties
- Applicant
- Science Development Corp.
Mchenry, IL, US - Received
- September 28, 1983
- Decision date
- January 27, 1984
- 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 |
|---|---|---|
| K843617 | SDC Silicone Sump DrainGBX · Traditional | 10/24/1984SE |
| K842491 | SDC Silicone Forcep Shods Product · Traditional | 08/10/1984SE |
| K832090 | SCD Skin Temp. Sensors #3400 EtcFLL · Traditional | 10/31/1983SE |
| K832392 | SDC Oral-Rectal Temp. ProbeFLL · Traditional | 09/12/1983SE |
| K832391 | QT-100 Electronic Temp. MonitorFLL · Traditional | 09/12/1983SE |
| K830353 | Esophageal Probe W/Temp. IndicatorFLL · Traditional | 04/06/1983SE |
| K830329 | Esophageal StethoscopeBZW · Traditional | 03/11/1983SE |
| K830039 | SDC Rectal Temp. Probe Product #1020FLL · Traditional | 02/23/1983SE |
Questions and answers
When was SDC Vascular Ties cleared by the FDA?
SDC Vascular Ties (K833355) received a 510(k) decision of Substantially Equivalent on January 27, 1984, 121 days after the submission was received.
What is the product code of K833355?
The FDA product code is KDC – Instrument, Surgical, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.