Surgical Instrument, Disposable
FDA 510(k) K940684 · Her-Mar, Inc.
510(k) numberK940684
Submission
- Device name
- Surgical Instrument, Disposable
- Applicant
- Her-Mar, Inc.
Miami Beach, FL, US - Received
- February 10, 1994
- Decision date
- March 14, 1994
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K810814 | Thermometer, Electronic ClinicalFLL · Traditional | 04/10/1981SE |
Questions and answers
When was Surgical Instrument, Disposable cleared by the FDA?
Surgical Instrument, Disposable (K940684) received a 510(k) decision of Substantially Equivalent on March 14, 1994, 32 days after the submission was received.
What is the product code of K940684?
The FDA product code is MDM – Instrument, Manual, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.