Codman Disposable Perforators
FDA 510(k) K183581 · Integra Lifesciences Corp.
510(k) numberK183581
Submission
- Device name
- Codman Disposable Perforators
- Applicant
- Integra Lifesciences Corp.
Mansfield, MA, US - Received
- December 21, 2018
- Decision date
- January 20, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K254177 | Disposable Sterile Skull Drill (LZ)HBF · Traditional | Guizhou Zirui Technology Co., Ltd. | 09/11/2026SE |
| K231403 | evoDrill Cranial PerforatorHBF · Traditional | Evonos GmbH & Co. KG | 03/06/2024SE |
| K213228 | NeuroLine Disposable Cranial Perforator with Hudson endHBF · Traditional | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | 06/20/2022SE |
| K141455 | Easydrill Autostop Cranial PerforatorHBF · Traditional | Micromar Ind. Com. , Ltd. | 03/16/2015SE |
| K121253 | Meridian Cranial PerforatorHBF · Traditional | Adeor Medical Technologies GmbH | 07/17/2012SE |
| K082010 | Stryker Disposable Cranial Perforator BitHBF · Traditional | Stryker Ireland Ltd., Instruments Division | 12/29/2008SE |
| K082637 | Cranial PerforatorHBF · Traditional | The Anspach Effort, Inc. | 12/22/2008SE |
| K073336 | Codman Craniotomy Kit, Models 26-1229, 26-1230, 26-1231HBF · Special | Codman & Shurtleff, Inc. | 01/04/2008SE |
| K071931 | Codman Disposable Perforator, Model(S) 26-1222, 26-1223HBF · Traditional | Codman & Shurtleff, Inc. | 10/22/2007SE |
| K032970 | Acra-Cut Xpress 120HBF · Traditional | Acra Cut, Inc. | 12/08/2003SE |
More from Acra Cut, Inc.
| 510(k) | Device | Decision |
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| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 10/08/2025SE |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG · Special | 04/09/2025SE |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/11/2024SE |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/11/2023SE |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 08/22/2022SE |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Special | 07/15/2022SE |
| K210128 | INTEGRA Wound Matrix (Macro-Channels)KGN · Traditional | 10/08/2021SE |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…HRS · Traditional | 07/27/2021SE |
| K193346 | Codman Surgical Patties & StripsHBA · Traditional | 11/20/2020SE |
| K201507 | Cadence Total Ankle SystemHSN · Special | 06/29/2020SE |
Questions and answers
When was Codman Disposable Perforators cleared by the FDA?
Codman Disposable Perforators (K183581) received a 510(k) decision of Substantially Equivalent on January 20, 2019, 30 days after the submission was received.
What is the product code of K183581?
The FDA product code is HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4305.