FDA Product Code
FDA Product Code HAW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4560
510(k) Clearances — 425 records · page 5 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K901670 | GNOMOS STEREOTACTIC DEVICE | Medical Equipment Development Co., Inc. | 1990-07-03 | Traditional | PDF ↗ |
| K900200 | COOK STEREOTAXIC GUIDE | Cook, Inc. | 1990-05-31 | Traditional | PDF ↗ |
| K894387 | WESTCO MADAYAG PAB NEEDLE | Western Medical, Ltd. | 1989-11-07 | Traditional | PDF ↗ |
| K894263 | CASS SYSTEM | Medical Instrumentation & Diagnostics Corp.(Midco) | 1989-09-01 | Traditional | PDF ↗ |
| K881132 | LAITINEN'S TRIGEMINUS STEREOGUIDE | Sandstrom Trade & Technology, Inc. | 1988-08-09 | Traditional | PDF ↗ |
| K881131 | THE LAITINEN STEREOTACTIC SYSTEM | Sandstrom Trade & Technology, Inc. | 1988-08-01 | Traditional | PDF ↗ |
| K874693 | OBT STEREOTACTIC SYSTEM | Tipal Instruments , Ltd. | 1988-03-11 | Traditional | PDF ↗ |
| K874833 | ARC ADAPTER ASSEMBLY | Medical Equipment Development Co., Inc. | 1988-03-03 | Traditional | PDF ↗ |
| K872877 | TARGET PROGRAM & EPSON HX-20 COMPUTER | Walter Lorenz Surgical, Inc. | 1988-02-12 | Traditional | PDF ↗ |
| K871046 | COMPASS STEREOTACTIC POSITIONING SYSTEM | Stereotactic Medical Systems, Inc. | 1987-05-08 | Traditional | PDF ↗ |
| K861629 | KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES | Downs Surgical , Ltd. | 1986-08-12 | Traditional | PDF ↗ |
| K862220 | COMPASS CT STEREOTACTIC ADAPTATION SYSTEM | Stereotactic Medical Systems, Inc. | 1986-06-18 | Traditional | PDF ↗ |
| K854475 | GHAJAR INTRAVENTRICULAR CATHETER GUIDE | Sparta Instrument Corp. | 1986-02-20 | Traditional | PDF ↗ |
| K852662 | GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY | Neurosurgical Devices, Inc. | 1985-08-21 | Traditional | PDF ↗ |
| K852477 | KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS | Mayo Clinic | 1985-07-30 | Traditional | PDF ↗ |
| K851973 | DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY | Diasonics, Inc. | 1985-07-26 | Traditional | PDF ↗ |
| K851659 | SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE | Medco Products, Co., Inc. | 1985-07-01 | Traditional | PDF ↗ |
| K833484 | COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC | A. Patil, M.D. | 1983-12-29 | Traditional | PDF ↗ |
| K830999 | DAP II BIOPSY GUIDE | Rapid Machine & Tool Corp. | 1983-07-12 | Traditional | PDF ↗ |
| K831329 | PMT VAXIOM STEREOTACTIC SYS #FX001 | Progress Mankind Technology | 1983-06-15 | Traditional | PDF ↗ |
| K823424 | MENISCECTOMY TRAY #9715 | Concept, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K823675 | FRONING GUIDANCE SYSTEM #TX-8200 | Today'S Machining & Design, Inc. | 1983-01-05 | Traditional | PDF ↗ |
| K812744 | LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER | Progress Mankind Technology | 1981-12-03 | Traditional | PDF ↗ |
| K811452 | BROWN-ROBERTS-WELLS STEREOTAXIC SYTEM | Trent Wells, Inc. | 1981-06-02 | Traditional | PDF ↗ |
| K790502 | DYONICS STEROTOXIC POSITIONER | Dyonics, Inc. | 1979-04-05 | Traditional | PDF ↗ |
Product code HAW · Class II · Neurology. Data: openFDA.