Product code FZX
- Device name
- Guide, Surgical, Instrument
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- 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 |
|---|---|---|---|
| K914715 | PARALLELING GUIDES | Implant Corp. of America | 1994-02-16 |
| K871413 | CIVCO STEPPER | CIVCO Medical Instruments Co., Inc. | 1987-07-14 |
| K871503 | BIOPSY NEEDLE GUIDE KIT, STERILE | Amedic USA | 1987-07-10 |
| K862564 | A.C.L. GUIDE KIT | Aspen Laboratories, Inc. | 1986-08-18 |
| K854262 | MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY | Meadox Surgimed, Inc. | 1985-12-24 |
| K852402 | NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER | North American Instrument Corp. | 1985-07-11 |
| K842698 | BRITISH SPINAL FUSION SET | Downs Surgical , Ltd. | 1984-09-12 |
| K841618 | THREADING TUBE | Plastafil, Inc. | 1984-08-27 |
| K841619 | DRILL GUIDE | Plastafil, Inc. | 1984-07-11 |
| K841297 | TECHMEDICA DRILL GUIDE | Techmedica, Inc. | 1984-04-25 |
| K840835 | STRAITH DRAIN INSERTER | Surgical Technology Laboratories, Inc. | 1984-04-23 |
| K834350 | ACUFEX DREZ COMMUNICATING DRILL GUIDE | Acufex Microsurgical, Inc. | 1984-03-19 |
| K830720 | GRAF MENISCAL SUTURE SET | Acufex Microsurgical, Inc. | 1983-06-16 |
| K821618 | DISPOSABLE NEEDLE HOLDERS | Medcare Products | 1982-06-21 |
| K810888 | BOUNDARY TUBING HOLDERS | The Buckeye Cellulose Corp. | 1981-04-23 |
| K810788 | SURGICAL TUBE HOLDER | The Urology Group | 1981-04-17 |
| K802093 | GABBAY-FRATER SUTURE GUIDE | Howmedica Corp. | 1980-09-26 |
| K792468 | FEEDING TUBE PLACEMENT STYLET | Biosearch Medical Products, Inc. | 1979-12-27 |
| K790872 | ENTERIC TUBE GUIDE | Biosearch Medical Products, Inc. | 1979-05-23 |
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| Primary DI | Brand | Company | Published |
|---|---|---|---|
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| 00841731153128 | ARTEMIS FUZE | VILEX LLC | 2026-07-22 |
| 00888118147738 | LEVEL ONE EXTREMITY | KLS-Martin L.P. | 2026-07-21 |
| 00888118147745 | LEVEL ONE EXTREMITY | KLS-Martin L.P. | 2026-07-21 |
| 00888118147721 | LEVEL ONE EXTREMITY | KLS-Martin L.P. | 2026-07-21 |
| 00888118147714 | LEVEL ONE EXTREMITY | KLS-Martin L.P. | 2026-07-21 |
| 00888118147271 | LEVEL ONE EXTREMITY | KLS-Martin L.P. | 2026-07-21 |
| 00888118147264 | LEVEL ONE EXTREMITY | KLS-Martin L.P. | 2026-07-21 |
| 00888118147257 | LEVEL ONE EXTREMITY | KLS-Martin L.P. | 2026-07-21 |
| 00888118147240 | LEVEL ONE EXTREMITY | KLS-Martin L.P. | 2026-07-21 |
| 00888118147233 | LEVEL ONE EXTREMITY | KLS-Martin L.P. | 2026-07-21 |
| 00888118147226 | LEVEL ONE EXTREMITY | KLS-Martin L.P. | 2026-07-21 |
| 03700569621261 | Newclip Instruments | NEWCLIP TECHNICS | 2026-05-11 |
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