Product code HAO
- Device name
- Instrument, Surgical, Non-Powered
- Medical specialty
- Neurology
- Device class
- 1
- Regulation number
- 882.4535
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220920 | Matreneu Percutaneous Balloon Compression Kit | Shenzhen Shineyard Medical Device Co. , Ltd. | 2022-09-07 |
| K940973 | MULLAN GANGLION MICROCOMPRESSION SET | Cook, Inc. | 1995-09-29 |
| K951492 | RIB RESECTOR | United States Surgical, A Division of Tyco Healthc | 1995-05-18 |
| K943115 | AUTO SUTURE PITUITARY SPINAL RONGEUR | United States Surgical, A Division of Tyco Healthc | 1994-07-25 |
| K942967 | AUTO SUTURE SPINAL CURETTE | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942968 | AUTO SUTURE SPINAL OSTEOTOME | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942969 | AUTO SUTURE SPINAL NERVE HOOK | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942970 | AUTO SUTURE SPINAL ELEVATOR | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942971 | AUTO SUTURE SPINAL DISSECTOR | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K923723 | SILICONE BRAIN SPATULA SET | Redmond Neurosurgical, Inc. | 1992-08-12 |
| K910225 | BONE PAD REMOVER | Acra Cut, Inc. | 1991-02-12 |
| K910226 | DURAL DISSECTORS | Acra Cut, Inc. | 1991-02-12 |
| K902850 | ZEPPELIN INSTRUMENTS | Ruggles Corp. | 1990-07-18 |
| K892546 | TAYLOR SPINAL RETRACTOR | Zinnanti Surgical Instruments, Inc. | 1989-05-11 |
| K882422 | DISPOSABLE ARACHNOID KNIFE | Microbio-Medics, Inc. | 1988-09-06 |
| K880278 | MALLEABLE PTFE COATED BRAIN SPATULAE | Downs Surgical , Ltd. | 1988-02-11 |
| K874962 | FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS | Solway, Inc. | 1988-02-02 |
| K874630 | RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS | Downs Surgical , Ltd. | 1987-12-23 |
| K863415 | RAYLOR BONE IMPACTORS | Cedar Surgical, Inc. | 1986-09-24 |
| K863416 | RAYLOR MINI-PROBE | Cedar Surgical, Inc. | 1986-09-24 |
| K862331 | FUJITSU MALLEABLE - TIP BRAIN SPATULA | Downs Surgical , Ltd. | 1986-07-01 |
| K861630 | NEUROSURGICAL INSTURMENTS (VARIOUS) | Downs Surgical , Ltd. | 1986-05-09 |
| K832343 | DERMALAND DURAL HOOKS | National Fabtronix, Inc. | 1983-08-12 |
| K822048 | H-H NERVE ROOT RETRACTOR | Holter-Hausner Intl. | 1982-07-22 |
| K821357 | MODIFIED NEURO SURGERY NIBBLING FORCEPS | Downs Surgical , Ltd. | 1982-05-14 |
| K802726 | INSTRUMENTS NONSTERILE & STERILE | Ascep, Inc. | 1980-11-19 |
| K801760 | FIELD-LEE BRAIN BIOPSY NEEDLE | American V. Mueller | 1980-09-09 |
| K780579 | SUBCUPASS TUNNELING TOOL | Medtronic Vascular | 1978-05-19 |
| K780520 | VAS APPROXIMATOR | Edward Weck, Inc. | 1978-05-16 |
| K772371 | BAYONET SURGICAL INSTRUMENTS | Edward Weck, Inc. | 1978-01-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810220800515 | Adler Instrument Company | Adler, Inc. | 2026-07-30 |
| 00810220800508 | Adler Instrument Company | Adler, Inc. | 2026-07-30 |
| 00190776407377 | Millennium | Avalign Technologies, Inc. | 2026-07-28 |
| 00190776407384 | Millennium | Avalign Technologies, Inc. | 2026-07-28 |
| 00190776404109 | Millennium | Avalign Technologies, Inc. | 2026-07-24 |
| 00190776404031 | Millennium | Avalign Technologies, Inc. | 2026-07-22 |
| 00190776404079 | Millennium | Avalign Technologies, Inc. | 2026-07-22 |
| 00190776404062 | Millennium | Avalign Technologies, Inc. | 2026-07-22 |
| 00190776404055 | Millennium | Avalign Technologies, Inc. | 2026-07-22 |
| 00190776404048 | Millennium | Avalign Technologies, Inc. | 2026-07-22 |
| 00190776404024 | Millennium | Avalign Technologies, Inc. | 2026-07-22 |
| 00190776404017 | Millennium | Avalign Technologies, Inc. | 2026-07-22 |
| 00190776404000 | Millennium | Avalign Technologies, Inc. | 2026-07-22 |
| 00190776400262 | Millennium | Avalign Technologies, Inc. | 2026-07-21 |
| 00190776400545 | Millennium | Avalign Technologies, Inc. | 2026-07-19 |
| 00190776402105 | Millennium | Avalign Technologies, Inc. | 2026-07-19 |
| 00190776400286 | Millennium | Avalign Technologies, Inc. | 2026-07-17 |
| 04058749078794 | NA | Fehling Instruments GmbH & Co. KG | 2026-07-17 |
| 00190776400231 | Millennium | Avalign Technologies, Inc. | 2026-07-16 |
| 00190776395445 | Millennium | Avalign Technologies, Inc. | 2026-07-14 |
| 00190776395735 | Millennium | Avalign Technologies, Inc. | 2026-07-14 |
| 00190776395742 | Millennium | Avalign Technologies, Inc. | 2026-07-14 |
| 00190776395759 | Millennium | Avalign Technologies, Inc. | 2026-07-14 |
| 00190776395391 | Millennium | Avalign Technologies, Inc. | 2026-07-13 |
| 00190776395407 | Millennium | Avalign Technologies, Inc. | 2026-07-13 |
| 00190776395414 | Millennium | Avalign Technologies, Inc. | 2026-07-13 |
| 00190776395421 | Millennium | Avalign Technologies, Inc. | 2026-07-13 |
| 04946329056440 | CEA Scissors 170 mm, 35 deg. Downward Cvd | MIZUHO CORPORATION | 2026-05-29 |
| 00887482044100 | Symmetry Carroll | ASPEN SURGICAL PRODUCTS, INC. | 2022-08-30 |
| 03664539003405 | NA | DIXI MEDICAL | 2022-01-01 |