Acu-Hemostatic Ring
FDA 510(k) K933866 · Acuderm, Inc.
510(k) numberK933866
Submission
- Device name
- Acu-Hemostatic Ring
- Applicant
- Acuderm, Inc.
Ft. Lauderdale, FL, US - Received
- August 6, 1993
- Decision date
- December 1, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code MDM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K073664 | Frontline Medical Safetynet Guidewire IntroducerMDM · Traditional | Injectimed, Inc. | 08/08/2008SE |
| K050575 | Futumeds No Patient Contact Safety Lancet with Pals SystemMDM · Traditional | Futumeds Sdn Bhd | 08/15/2005SE |
| K050957 | EutrocharMDM · Traditional | Special Devices, Inc. | 05/18/2005SE |
| K023173 | Andrews Introducer, Model ASI01MDM · Traditional | Andrews Surgical Innovations, Ltd. | 12/18/2002SE |
| K022059 | Microvasive Pulmonary GuidewireMDM · Traditional | Boston Scientific Corp | 11/13/2002SE |
| K013040 | Light Saber Introducer NeedleMDM · Traditional | Minrad, Inc. | 12/07/2001SE |
| K010184 | Chess Hand Surgery SystemMDM · Traditional | Canica Design, Inc. | 06/22/2001SE |
| K990062 | SaphliftMDM · Traditional | Genzyme Surgical Product (Genzyme Biosurgery) | 03/30/1999SE |
| K981579 | Endopouch Pro Specimen Retrieval BagMDM · Traditional | ETHICON, Inc. | 07/09/1998SE |
| K943968 | TunnelerMDM · Traditional | Denver Biomedicals, Inc. | 03/01/1995SE |
More from Denver Biomedicals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K933516 | Acu-E PunchLRY · Traditional | 03/24/1994SE |
| K933265 | Acu-Dispo-Ce(Tm)MDM · Traditional | 03/07/1994SE |
| K933137 | Acu-Suture KitLRO · Traditional | 02/22/1994SE |
| K930043 | Acu-EvacFYD · Traditional | 02/09/1994SE |
| K915000 | Acu-GuardGEX · Traditional | 01/27/1992SE |
| K891334 | Acu-CuretteFZS · Traditional | 04/11/1989SE |
| K874024 | Acu-Micro-NeedleFMI · Traditional | 11/23/1987SE |
| K854877 | Acu-Syringe W/Wo NeedlesFMF · Traditional | 02/19/1986SE |
| K832583 | Sabouraud Dextrose AgarJSJ · Traditional | 09/12/1983SE |
| K832582 | Mycosel AgarJSJ · Traditional | 09/12/1983SE |
Questions and answers
When was Acu-Hemostatic Ring cleared by the FDA?
Acu-Hemostatic Ring (K933866) received a 510(k) decision of Substantially Equivalent on December 1, 1993, 117 days after the submission was received.
What is the product code of K933866?
The FDA product code is MDM – Instrument, Manual, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.