Acra-Cut
510(k) K944311
Acra-Cut is a medical device (FDA Class II; FDA product code HBO, Clip, Scalp) made by Acra-Cut Inc, cleared under FDA 510(k) K944311 on 18 Nov 1994, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK944311 | Date18 Nov 1994 | StatusActive |
Official records
- FDA 510(k) database K944311
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HBO
- FDA applicant
- Acra Cut, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4150
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K944311
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Acra Clip 500-103 | 500-103 / 500-103 | 00810607000132 | — | On the market |
| Acra Clip 500-104 | 500-104 / 500-104 | 00810607000149 | — | On the market |
| Acra Clip 500-105 | 500-105 / 500-105 | 00810607000156 | — | On the market |
| Acra Clip 500-106 | 500-106 / 500-106 | 00810607000163 | — | On the market |
| Acra Clip 500-108 | 500-108 / 500-108 | 00810607000170 | — | On the market |
| Acra Clip 500-109 | 500-109 / 500-109 | 00810607000187 | — | On the market |
| Acra Clip 500-110 | 500-110 / 500-110 | 00810607000194 | — | On the market |
| Acra Clip 500-111 | 500-111 / 500-111 | 00810607000200 | — | On the market |
| Acra Clip 500-112 | 500-112 / 500-112 | 00810607000217 | — | On the market |
Similar devices
Other devices filed under FDA product code HBO (Clip, Scalp).
- STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 by Rudolf Storz GmbH
- RANEY CLIPS by Zimmer, Inc.
- CODMAN® 201035 20-1035 by Integra LifeSciences Production Corporation
- Raney Clips Kit by Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.
- CASPAR SCALP CLIP, APPLIER by Aesculap Instruments Corp.
- RANEY AND LEROY-RANEY SCALP CLIP by New England Surgical Instrument Corp.
- Medtronic Clip Gun Kit by Medtronic Neurosurgery
- Clip Gun with Raney Type Scalp Clips by Omni Medical Designs
- Codman RF-12 Disposable Scalp Clip Applier by Codman & Shurtleff, Inc.
- SCALPFIX CLIP SYSTEM by AESCULAP, INC.