HAO · Class I · 21 CFR 882.4535

FDA Product Code HAO: Instrument, Surgical, Non-powered

Leading manufacturers include United States Surgical, A Division of Tyco Healthc, Medtronic Vascular and Shenzhen Shineyard Medical Device Co. , Ltd..

34
Total
34
Cleared
47d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Instrument, Surgical, Non-powered Devices (Product Code HAO)

34 devices
1–24 of 34
Cleared Sep 07, 2022
Matreneu Percutaneous Balloon Compression Kit
K220920
Shenzhen Shineyard Medical Device Co. , Ltd.
Neurology · 161d
Cleared May 18, 1995
RIB RESECTOR
K951492
United States Surgical, A Division of Tyco Healthc
Neurology · 48d
Cleared Jul 25, 1994
AUTO SUTURE PITUITARY SPINAL RONGEUR
K943115
United States Surgical, A Division of Tyco Healthc
Neurology · 28d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL CURETTE
K942967
United States Surgical, A Division of Tyco Healthc
Neurology · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL OSTEOTOME
K942968
United States Surgical, A Division of Tyco Healthc
Neurology · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL NERVE HOOK
K942969
United States Surgical, A Division of Tyco Healthc
Neurology · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL ELEVATOR
K942970
United States Surgical, A Division of Tyco Healthc
Neurology · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL DISSECTOR
K942971
United States Surgical, A Division of Tyco Healthc
Neurology · 30d
Cleared May 19, 1978
SUBCUPASS TUNNELING TOOL
K780579
Medtronic Vascular
Neurology · 39d
Cleared Oct 28, 1977
PERCUPASS TUNNELING TOOL MODEL 3452
K772013
Medtronic Vascular
Neurology · 3d

About Product Code HAO - Regulatory Context

510(k) Submission Activity

34 total 510(k) submissions under product code HAO since 1976, with 34 receiving FDA clearance (average review time: 47 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.