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
Stable submission activity - 0 submissions in the last 2 years

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 Aug 12, 1992
SILICONE BRAIN SPATULA SET
K923723
Redmond Neurosurgical, Inc.
Neurology · 16d
Cleared Feb 12, 1991
BONE PAD REMOVER
K910225
Acra Cut, Inc.
Neurology · 25d
Cleared Feb 12, 1991
DURAL DISSECTORS
K910226
Acra Cut, Inc.
Neurology · 25d
Cleared Jul 18, 1990
ZEPPELIN INSTRUMENTS
K902850
Ruggles Corp.
Neurology · 19d
Cleared May 11, 1989
TAYLOR SPINAL RETRACTOR
K892546
Zinnanti Surgical Instruments, Inc.
Neurology · 30d
Cleared Sep 06, 1988
DISPOSABLE ARACHNOID KNIFE
K882422
Microbio-Medics, Inc.
Neurology · 85d
Cleared Feb 11, 1988
MALLEABLE PTFE COATED BRAIN SPATULAE
K880278
Downs Surgical , Ltd.
Neurology · 20d
Cleared Feb 02, 1988
FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS
K874962
Solway, Inc.
Neurology · 62d
Cleared Dec 23, 1987
RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS
K874630
Downs Surgical , Ltd.
Neurology · 43d
Cleared Sep 24, 1986
RAYLOR BONE IMPACTORS
K863415
Cedar Surgical, Inc.
Neurology · 21d
Cleared Sep 24, 1986
RAYLOR MINI-PROBE
K863416
Cedar Surgical, Inc.
Neurology · 21d
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 Aug 12, 1983
DERMALAND DURAL HOOKS
K832343
National Fabtronix, Inc.
Neurology · 25d
Cleared Jul 22, 1982
H-H NERVE ROOT RETRACTOR
K822048
Holter-Hausner Intl.
Neurology · 10d

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 remained relatively stable over the observed period, with 0 submissions in the last 24 months.