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 |
| K942971 | AUTO SUTURE SPINAL DISSECTOR | 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 |
| K942969 | AUTO SUTURE SPINAL NERVE HOOK | 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 |
| K942967 | AUTO SUTURE SPINAL CURETTE | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K923723 | SILICONE BRAIN SPATULA SET | Redmond Neurosurgical, Inc. | 1992-08-12 |
| K910226 | DURAL DISSECTORS | Acra Cut, Inc. | 1991-02-12 |
| K910225 | BONE PAD REMOVER | 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 |
| K863416 | RAYLOR MINI-PROBE | Cedar Surgical, Inc. | 1986-09-24 |
| K863415 | RAYLOR BONE IMPACTORS | 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 |
| K772389 | DANDY HEMOSTATIC FORCEPS | Edward Weck, Inc. | 1978-01-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04946329056457 | CEA Scissors 180 mm, Sideward Cvd. | MIZUHO CORPORATION | 2026-05-29 |
| 04946329150261 | Micro Scissors Streamline L, 220 mm Curved, Super Fine Tip | MIZUHO CORPORATION | 2026-05-29 |
| 04946329150254 | Micro Scissors Streamline L, 220 mm Straight, Super Fine Tip | MIZUHO CORPORATION | 2026-05-29 |
| 04946329150247 | Micro Scissors Streamline M, 190 mm Curved, Super Fine Tip | MIZUHO CORPORATION | 2026-05-29 |
| 04946329150230 | Micro Scissors Streamline M, 190 mm Straight, Super Fine Tip | MIZUHO CORPORATION | 2026-05-29 |
| 04946329150223 | Micro Scissors Streamline S, 175 mm Curved, Super Fine Tip | MIZUHO CORPORATION | 2026-05-29 |
| 04946329150216 | Micro Scissors Streamline S, 175 mm Straight, Super Fine Tip | MIZUHO CORPORATION | 2026-05-29 |
| 04946329077629 | Bulldog Clamp 57 mm, S Cvd. | MIZUHO CORPORATION | 2026-05-29 |
| 04946329077612 | Bulldog Clamp 67 mm, L Cvd. | MIZUHO CORPORATION | 2026-05-29 |
| 04946329077605 | Bulldog Clamp 54 mm, L-Shaped. | MIZUHO CORPORATION | 2026-05-29 |
| 04946329077599 | Bulldog Clamp 67 mm, S Str. | MIZUHO CORPORATION | 2026-05-29 |
| 04946329077476 | Pediatric Mosquito Applier without Hook Str | MIZUHO CORPORATION | 2026-05-29 |
| 04946329056440 | CEA Scissors 170 mm, 35 deg. Downward Cvd | MIZUHO CORPORATION | 2026-05-29 |
| 04946329056464 | CEA Micro Scissors 170 mm, 35 deg. Downward Cvd. | MIZUHO CORPORATION | 2026-05-29 |
| 04946329056471 | CEA Thin Needle Holder 170 mm | MIZUHO CORPORATION | 2026-05-29 |
| 04946329056488 | CEA Micro Forceps 180 mm, Cvd. | MIZUHO CORPORATION | 2026-05-29 |
| 04946329056495 | CEA Micro Forceps 180 mm, L Str. | MIZUHO CORPORATION | 2026-05-29 |
| 04946329056501 | CEA Micro Forceps 150 mm, S Str. | MIZUHO CORPORATION | 2026-05-29 |
| 04946329058802 | Yasargil micro raspatory, curved, 18.5 cm | MIZUHO CORPORATION | 2026-05-29 |
| 04946329058987 | Micro Scissors 130 mm, FH | MIZUHO CORPORATION | 2026-05-29 |
| 04946329077582 | Bulldog Clamp 82 mm, L Str. | MIZUHO CORPORATION | 2026-05-29 |
| 07613327262322 | XIA | Stryker Corporation | 2019-11-21 |
| 07613327264432 | XIA 4.5 | Stryker Corporation | 2019-11-21 |
| 07613327264951 | XIA 3 | Stryker Corporation | 2019-11-21 |
| 07613327263787 | RELIANCE LITe | Stryker Corporation | 2019-11-20 |
| 07613327263923 | RELIANCE LITe | Stryker Corporation | 2019-11-20 |
| 07613327265897 | RELIANCE LITe | Stryker Corporation | 2019-11-20 |
| 07613327265910 | RELIANCE LITe | Stryker Corporation | 2019-11-20 |
| 07613327265934 | RELIANCE LITe | Stryker Corporation | 2019-11-20 |
| 07613327266016 | RELIANCE LITe | Stryker Corporation | 2019-11-20 |