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 |
|---|---|---|---|
| G586N93065380 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
| G586N93065370 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
| G28435301 | Screwdriver | Neurovention LLC | 2022-06-21 |
| 07613327262322 | XIA | Stryker Corporation | 2019-11-21 |
| 07613327264432 | XIA 4.5 | Stryker Corporation | 2019-11-21 |
| 07613327264951 | XIA 3 | Stryker Corporation | 2019-11-21 |
| 07613327276176 | RADIUS | Stryker Corporation | 2019-11-21 |
| 07613327271447 | OASYS | Stryker Corporation | 2019-11-21 |
| 07613327263787 | RELIANCE LITe | Stryker Corporation | 2019-11-20 |
| 07613327265934 | RELIANCE LITe | Stryker Corporation | 2019-11-20 |
| 07613327265910 | RELIANCE LITe | Stryker Corporation | 2019-11-20 |
| 07613327265897 | RELIANCE LITe | Stryker Corporation | 2019-11-20 |
| 07613327263923 | RELIANCE LITe | Stryker Corporation | 2019-11-20 |
| 07613327266016 | RELIANCE LITe | Stryker Corporation | 2019-11-20 |
| 10381780167778 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-10-23 |
| 10381780165736 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-02-16 |
| 10381780165996 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-02-16 |
| 10381780167761 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780165828 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780165811 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780165804 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780024965 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-24 |
| 10381780165743 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-10-31 |
| 10381780165767 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-09-29 |
| 10381780167808 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-19 |
| 10381780167822 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-19 |
| 10381780167747 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-19 |
| 10381780167730 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-19 |
| 10381780167723 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-19 |
| 10381780035343 | NeuroBalloon™ | Integra LifeSciences Switzerland Sàrl | 2016-08-08 |