Auto-Clip
FDA 510(k) K771021 · Axiom Medical, Inc.
510(k) numberK771021
Submission
- Device name
- Auto-Clip
- Applicant
- Axiom Medical, Inc.
Mchenry, IL, US - Received
- June 6, 1977
- Decision date
- June 14, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSS – Clip, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3250
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DSS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983744 | Mcas (Modular Clip Applier System)DSS · Traditional | Applied Medical Resources | 01/21/1999SE |
| K961333 | Heartport Multifire Clip ApplierDSS · Traditional | Heartport, Inc. | 11/15/1996SE |
| K920104 | Identi Loops Degania SiliconeDSS · Traditional | Puritas Health Care, Inc. | 04/20/1992SE |
| K920676 | Rmi SofclampDSS · Traditional | Research Medical, Inc. | 04/15/1992SE |
| K914523 | Cri Vessel Occlusin System/Cri Occlusion CoilDSS · Traditional | Catheter Research C/O Burditt, Bowles & Radzius | 01/10/1992SE |
| K901303 | Horizon Surgical Ligating and Marking ClipDSS · Traditional | Horizon Surgical, Inc. | 06/05/1990SE |
| K883909 | Surgical Spring ClipsDSS · Traditional | Applied Vascular Devices, Inc. | 12/27/1988SE |
More from Applied Vascular Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993592 | Axiom Multipurpose Wound DrainBSO · Traditional | 05/17/2000SE |
| K971851 | Interpleural Anesthesia CatheterBSO · Traditional | 01/22/1998SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | 03/10/1997SE |
| K934895 | Glassman Silicone CatheterEZL · Traditional | 10/13/1994SE |
| K922760 | Atraum Wound Dressing--ModificationKMF · Traditional | 10/30/1992SE |
| K905422 | PVC Round Wound DrainsGBX · Traditional | 02/11/1991SE |
| K904218 | Suction SystemGEA · Traditional | 10/31/1990SE |
| K904133 | Disposable Fluid Collection BagGBX · Traditional | 10/11/1990SE |
| K863247 | Axiom Trocar Thoracic CatheterGBS · Traditional | 08/29/1986SE |
| K861306 | Suction SystemGEA · Traditional | 06/09/1986SE |
Questions and answers
When was Auto-Clip cleared by the FDA?
Auto-Clip (K771021) received a 510(k) decision of Substantially Equivalent on June 14, 1977, 8 days after the submission was received.
What is the product code of K771021?
The FDA product code is DSS – Clip, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.3250.