HBO · Class II · 21 CFR 882.4150

FDA Product Code HBO: Clip, Scalp

Leading manufacturers include Codman & Shurtleff, Inc., Aesculap, Inc. and Zimmer, Inc..

11
Total
11
Cleared
86d
Avg days
1988
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 235d recently vs 72d historically

FDA 510(k) Cleared Clip, Scalp Devices (Product Code HBO)

11 devices
1–11 of 11
Cleared Jul 31, 2001
SCALPFIX CLIP SYSTEM
K012219
Aesculap, Inc.
General & Plastic Surgery · 15d
Cleared Feb 21, 1991
CODMAN DISPOSABLE SCALP CLIP APPLIER
K905433
Codman & Shurtleff, Inc.
Neurology · 79d
Cleared Dec 06, 1989
CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER
K894778
Codman & Shurtleff, Inc.
Neurology · 132d
Cleared May 31, 1988
RANEY CLIPS
K881265
Zimmer, Inc.
Neurology · 68d

About Product Code HBO - Regulatory Context

510(k) Submission Activity

11 total 510(k) submissions under product code HBO since 1988, with 11 receiving FDA clearance (average review time: 86 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - HBO Product Code

Recent submissions under HBO have taken an average of 235 days to reach a decision - up from 72 days historically. Manufacturers should account for longer review timelines in current project planning.

HBO devices are reviewed by the Neurology panel. Browse all Neurology devices →