Product code HBO
- Device name
- Clip, Scalp
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4150
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050044 | MEDTRONIC CLIP GUN KIT | Medtronic Neurosurgery | 2005-02-07 |
| K033660 | STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 | Rudolf Storz GmbH | 2004-01-07 |
| K012219 | SCALPFIX CLIP SYSTEM | Aesculap, Inc. | 2001-07-31 |
| K944311 | ACRA-CUT | Acra Cut, Inc. | 1994-11-18 |
| K905433 | CODMAN DISPOSABLE SCALP CLIP APPLIER | Codman & Shurtleff, Inc. | 1991-02-21 |
| K896723 | CLIP GUN WITH RANEY TYPE SCALP CLIPS | Omni Medical Designs | 1990-03-23 |
| K894778 | CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER | Codman & Shurtleff, Inc. | 1989-12-06 |
| K890443 | CASPAR SCALP CLIP, APPLIER | Aesculap Instruments Corp. | 1989-06-15 |
| K883963 | RANEY AND LEROY-RANEY SCALP CLIP | New England Surgical Instrument Corp. | 1988-10-07 |
| K881265 | RANEY CLIPS | Zimmer, Inc. | 1988-05-31 |
Related GUDID Devices#
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|---|---|---|---|
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| 00887482192641 | Symmetry Raney | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-20 |
| 00842962110683 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-03-30 |
| 00842962110645 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-03-30 |
| 00842962110638 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-03-30 |
| 00842962110652 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-03-30 |
| 00842962110669 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-03-30 |
| 00842962110676 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-03-30 |
| 00842962110690 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-03-30 |
| 00842962110706 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-03-30 |
| 00842962110713 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-03-30 |
| 00842962110720 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-03-30 |
| 00842962110737 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-03-30 |
| 00721902371592 | N/A | MEDTRONIC PS MEDICAL, INC. | 2020-09-12 |
| 70721902371591 | N/A | MEDTRONIC PS MEDICAL, INC. | 2020-09-12 |
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| 10381780511588 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-02-28 |
| 10381780513551 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-02-28 |
| 10381780513544 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-02-28 |
| 10381780511625 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-02-28 |
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| 10381780511601 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-02-28 |
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| 34026704631811 | WECK | TELEFLEX INCORPORATED | 2019-04-16 |
| 34026704630401 | WECK | TELEFLEX INCORPORATED | 2018-05-16 |
| 04038653162901 | AESCULAP | Aesculap AG | 2016-09-23 |
| 04038653221875 | AESCULAP | Aesculap AG | 2016-09-23 |
| 04026704418343 | WECK | TELEFLEX INCORPORATED | 2016-09-18 |
| 10381780159940 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10886704001171 | CODMAN | Cerenovus, Inc. | 2016-06-30 |