Codman Disposable Perforators
FDA 510(k) clearance K183581 · decided 2019-01-20
Clearance details
- K-number
- K183581
- Device name
- Codman Disposable Perforators
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2018-12-21
- Decision date
- 2019-01-20
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- HBF
- Device class
- 2
- Regulation number
- 882.4305
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| evoDrill Cranial Perforator (K231403) | Evonos GmbH & Co. KG | 2024-03-06 |
| NeuroLine Disposable Cranial Perforator with Hudson end (K213228) | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | 2022-06-20 |
| EASYDRILL AUTOSTOP CRANIAL PERFORATOR (K141455) | Micromar Ind. Com. , Ltd. | 2015-03-16 |
| MERIDIAN CRANIAL PERFORATOR (K121253) | Adeor Medical Technologies GmbH | 2012-07-17 |
| STRYKER DISPOSABLE CRANIAL PERFORATOR BIT (K082010) | Stryker Ireland Ltd., Instruments Division | 2008-12-29 |
| CRANIAL PERFORATOR (K082637) | The Anspach Effort, Inc. | 2008-12-22 |
| CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 (K073336) | Codman & Shurtleff, Inc. | 2008-01-04 |
| CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 (K071931) | Codman & Shurtleff, Inc. | 2007-10-22 |
| ACRA-CUT XPRESS 120 (K032970) | Acra Cut, Inc. | 2003-12-08 |
| ANSPACH ACCESS CRANIAL PERFORATOR (K982991) | The Anspach Effort, Inc. | 1998-10-21 |
| DISPOSABLE PERFORATOR (K933894) | Codman & Shurtleff, Inc. | 1993-12-10 |
| DISPOSABLE PERFORATOR (K924242) | Codman & Shurtleff, Inc. | 1993-07-08 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CODMAN Disposable Perforator 11mm. Cranial Perforator. recall (Z-0373-2026) | Integra LifeSciences Corp. (NeuroSciences) | 2025-11-03 |
| CODMAN Disposable Perforator 9mm. Cranial Perforator. recall (Z-0374-2026) | Integra LifeSciences Corp. (NeuroSciences) | 2025-11-03 |
| CODMAN Disposable Perforator, 14mm. Cranial perforator. recall (Z-1716-2025) | Integra LifeSciences Corp. (NeuroSciences) | 2025-05-06 |