Codman Disposable Scalp Clip Applier
FDA 510(k) K905433 · Codman & Shurtleff, Inc.
510(k) numberK905433
Submission
- Device name
- Codman Disposable Scalp Clip Applier
- Applicant
- Codman & Shurtleff, Inc.
Randolph, MA, US - Received
- December 4, 1990
- Decision date
- February 21, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code HBO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253814 | Raney Clips KitHBO · Traditional | Beijing Honghugaoxiang Science and Technology… | 07/21/2026SE |
| K050044 | Medtronic Clip Gun KitHBO · Special | Medtronic Neurosurgery | 02/07/2005SE |
| K033660 | Storz Raney Scalp Clip, Model 1-20-004-05HBO · Traditional | Rudolf Storz GmbH | 01/07/2004SE |
| K012219 | Scalpfix Clip SystemHBO · Special | Aesculap, Inc. | 07/31/2001SE |
| K944311 | Acra-CutHBO · Traditional | Acra Cut, Inc. | 11/18/1994SE |
| K896723 | Clip Gun with Raney Type Scalp ClipsHBO · Traditional | Omni Medical Designs | 03/23/1990SE |
| K894778 | Codman RF-12 Disposable Scalp Clip ApplierHBO · Traditional | Codman & Shurtleff, Inc. | 12/06/1989SE |
| K890443 | Caspar Scalp Clip, ApplierHBO · Traditional | Aesculap Instruments Corp. | 06/15/1989SE |
| K883963 | Raney and Leroy-Raney Scalp ClipHBO · Traditional | New England Surgical Instrument Corp. | 10/07/1988SE |
| K881265 | Raney ClipsHBO · Traditional | Zimmer, Inc. | 05/31/1988SE |
More from Zimmer, Inc.
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|---|---|---|
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetNRY · Traditional | 07/20/2020SE |
| K191237 | CERENOVUS Large Bore CatheterDQY · Traditional | 11/08/2019SE |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP…GWM · Special | 11/08/2017SE |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System…JXG · Traditional | 10/16/2017SE |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)JXG · Traditional | 10/03/2017SE |
| K171862 | GALAXY G3 Mini Microcoil Delivery SystemHCG · Traditional | 09/25/2017SE |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…HCG · Special | 07/14/2017SE |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpDQY · Special | 07/03/2017SE |
| K162563 | YOGA MicrocatheterDQY · Special | 01/05/2017SE |
| K162437 | Codman EDS3 CSF External Drainage SystemJXG · Traditional | 10/28/2016SE |
Questions and answers
When was Codman Disposable Scalp Clip Applier cleared by the FDA?
Codman Disposable Scalp Clip Applier (K905433) received a 510(k) decision of Substantially Equivalent on February 21, 1991, 79 days after the submission was received.
What is the product code of K905433?
The FDA product code is HBO – Clip, Scalp, a Class II (moderate risk) device regulated under 21 CFR 882.4150.