HBO
11 FDA 510(k) clearances · Product code
77 daysmedian time to decision
139 days90th percentile
11clearances measured
FDA profile
- Official device name
- Clip, Scalp
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4150
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1999: 4 · 2001: 2 · 2017: 12 · 2019: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Raney Clips Kit (K253814) | Beijing Honghugaoxiang Science and Technology Development CO | 2026-07-21 |
| MEDTRONIC CLIP GUN KIT (K050044) | Medtronic Neurosurgery | 2005-02-07 |
| STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 (K033660) | Rudolf Storz GmbH | 2004-01-07 |
| SCALPFIX CLIP SYSTEM (K012219) | Aesculap, Inc. | 2001-07-31 |
| ACRA-CUT (K944311) | Acra Cut, Inc. | 1994-11-18 |
| CODMAN DISPOSABLE SCALP CLIP APPLIER (K905433) | Codman & Shurtleff, Inc. | 1991-02-21 |
| CLIP GUN WITH RANEY TYPE SCALP CLIPS (K896723) | Omni Medical Designs | 1990-03-23 |
| CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER (K894778) | Codman & Shurtleff, Inc. | 1989-12-06 |
| CASPAR SCALP CLIP, APPLIER (K890443) | Aesculap Instruments Corp. | 1989-06-15 |
| RANEY AND LEROY-RANEY SCALP CLIP (K883963) | New England Surgical Instrument Corp. | 1988-10-07 |
| RANEY CLIPS (K881265) | Zimmer, Inc. | 1988-05-31 |
Track HBO automatically
Every clearance here is in the API, with alerts when new ones post.