Disposable Perforator
FDA 510(k) K933894 · Codman & Shurtleff, Inc.
510(k) numberK933894
Submission
- Device name
- Disposable Perforator
- Applicant
- Codman & Shurtleff, Inc.
Randolph, MA, US - Received
- August 10, 1993
- Decision date
- December 10, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HBF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K183581 | Codman Disposable PerforatorsHBF · Special | Integra Lifesciences Corp. | 01/20/2019SE |
| 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 |
More from Codman & Shurtleff, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 Disposable Perforator cleared by the FDA?
Disposable Perforator (K933894) received a 510(k) decision of Substantially Equivalent on December 10, 1993, 122 days after the submission was received.
What is the product code of K933894?
The FDA product code is HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4305.