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, Downs Surgical , Ltd. and Edward Weck, Inc..

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 Sep 29, 1995
MULLAN GANGLION MICROCOMPRESSION SET
K940973
Cook, Inc.
Neurology · 575d
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 11, 1989
TAYLOR SPINAL RETRACTOR
K892546
Zinnanti Surgical Instruments, Inc.
Neurology · 30d
Cleared Feb 11, 1988
MALLEABLE PTFE COATED BRAIN SPATULAE
K880278
Downs Surgical , Ltd.
Neurology · 20d
Cleared Dec 23, 1987
RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS
K874630
Downs Surgical , Ltd.
Neurology · 43d
Cleared Jul 01, 1986
FUJITSU MALLEABLE - TIP BRAIN SPATULA
K862331
Downs Surgical , Ltd.
Neurology · 12d
Cleared May 09, 1986
NEUROSURGICAL INSTURMENTS (VARIOUS)
K861630
Downs Surgical , Ltd.
Neurology · 10d
Cleared Jul 22, 1982
H-H NERVE ROOT RETRACTOR
K822048
Holter-Hausner Intl.
Neurology · 10d
Cleared May 14, 1982
MODIFIED NEURO SURGERY NIBBLING FORCEPS
K821357
Downs Surgical , Ltd.
Neurology · 8d
Cleared May 19, 1978
SUBCUPASS TUNNELING TOOL
K780579
Medtronic Vascular
Neurology · 39d
Cleared May 16, 1978
VAS APPROXIMATOR
K780520
Edward Weck, Inc.
Neurology · 46d
Cleared Jan 06, 1978
BAYONET SURGICAL INSTRUMENTS
K772371
Edward Weck, Inc.
Neurology · 10d
Cleared Jan 06, 1978
DANDY HEMOSTATIC FORCEPS
K772389
Edward Weck, Inc.
Neurology · 10d
Cleared Oct 28, 1977
PERCUPASS TUNNELING TOOL MODEL 3452
K772013
Medtronic Vascular
Neurology · 3d
Cleared Nov 30, 1976
VANDERBILT CURETTE
K761095
Codman & Shurtleff, Inc.
Neurology · 8d
Cleared Nov 30, 1976
VANDERBILT BLADE HOLDER
K761097
Codman & Shurtleff, Inc.
Neurology · 8d

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.