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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|---|---|---|---|
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| 00190446960379 | DYNANAIL HELIX | Medshape, Inc. | 2026-10-09 |
| 10840143919350 | AtriClip® Selection Guide | ATRICURE, INC. | 2026-10-09 |
| 06932503563857 | Additional Working Channel | Micro-Tech (Nanjing) Co., Ltd. | 2026-09-30 |
| 06932503563864 | Additional Working Channel | Micro-Tech (Nanjing) Co., Ltd. | 2026-09-30 |
| 06932503563871 | Additional Working Channel | Micro-Tech (Nanjing) Co., Ltd. | 2026-09-30 |
| 00810056993139 | corra | Carlsmed, Inc. | 2026-01-30 |
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