Omed Fabric Instrument Covers
FDA 510(k) K810269 · Omega-Med Intl., Inc.
510(k) numberK810269
Submission
- Device name
- Omed Fabric Instrument Covers
- Applicant
- Omega-Med Intl., Inc.
Mchenry, IL, US - Received
- February 2, 1981
- Decision date
- February 26, 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 |
|---|---|---|
| K842603 | Omed Dispos. Instrument Guards · Traditional | 09/05/1984SE |
| K832441 | Suture-Aid BootiesKDC · Traditional | 03/05/1984SE |
| K830484 | Omed Ident-I-Band · Traditional | 03/24/1983SE |
| K822284 | Comply Neuromuscular StimulatorIPF · Traditional | 09/17/1982SE |
| K821334 | Omed Fabric Instrument Covers-Radiopaq · Traditional | 05/24/1982SE |
| K813499 | Omed Disposable BulldogDXC · Traditional | 12/29/1981SE |
| K810883 | Omed Silicone Instrument CoversKDC · Traditional | 04/23/1981SE |
| K810260 | Omed Silicone LoopsKDC · Traditional | 02/26/1981SE |
Questions and answers
When was Omed Fabric Instrument Covers cleared by the FDA?
Omed Fabric Instrument Covers (K810269) received a 510(k) decision of Substantially Equivalent on February 26, 1981, 24 days after the submission was received.
What is the product code of K810269?
The FDA product code is KDC – Instrument, Surgical, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.