Davis & Geck Needle/Sharps Counter
FDA 510(k) K811191 · Davis & Geck, Inc.
510(k) numberK811191
Submission
- Device name
- Davis & Geck Needle/Sharps Counter
- Applicant
- Davis & Geck, Inc.
Mchenry, IL, US - Received
- April 30, 1981
- Decision date
- May 27, 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 |
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Questions and answers
When was Davis & Geck Needle/Sharps Counter cleared by the FDA?
Davis & Geck Needle/Sharps Counter (K811191) received a 510(k) decision of Substantially Equivalent on May 27, 1981, 27 days after the submission was received.
What is the product code of K811191?
The FDA product code is KDC – Instrument, Surgical, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.