Product code GDG
- Device name
- Hook, Surgical, General & Plastic Surgery
- 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 |
|---|---|---|---|
| K900069 | MODIFIED PGL ABSORBABLE STAPLE* | United States Surgical, A Division of Tyco Healthc | 1990-04-16 |
| K891898 | SKIN HOOKS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K864425 | RAYLOR(TM) DISSECTING HOOK | Cedar Surgical, Inc. | 1986-12-12 |
| K843136 | BRIMFIELD CANNULATED GRASPING HOOKS | Brimfield Scientific Instruments | 1984-09-25 |
| K841010 | SURGICAL HOOKS, VARIOUS | Premier Dental Products Co. | 1984-05-01 |
| K812562 | SURGICAL RETRACTOR & ELASTIC STAYS, DISP | Humboldt Products | 1981-10-02 |
| K791120 | MIDDLE EAR PICKS, HOOKS CURETTES, | Xomed, Inc. | 1979-07-10 |
| K780289 | NERVE APPROXIMATER | Edward Weck, Inc. | 1978-06-14 |
| K771187 | DERMAHOOK #382-805 | Edward Weck, Inc. | 1977-07-11 |
| K771190 | ABRAMSON TRACHEA HOOK & RETRACTOR | Edward Weck, Inc. | 1977-07-11 |
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|---|---|---|---|
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| 10850067560323 | MaxRetract | Surgical Principals, Inc | 2026-08-25 |
| 10850067560330 | MaxRetract | Surgical Principals, Inc | 2026-08-25 |
| 10850067560347 | MaxRetract | Surgical Principals, Inc | 2026-08-25 |
| 00190776419660 | Millennium | Avalign Technologies, Inc. | 2026-08-23 |
| 00190776417161 | Millennium | Avalign Technologies, Inc. | 2026-08-19 |
| 00190776417079 | Millennium | Avalign Technologies, Inc. | 2026-08-18 |
| 00190776422219 | Millennium | Avalign Technologies, Inc. | 2026-07-31 |
| 00190776407346 | Millennium | Avalign Technologies, Inc. | 2026-07-28 |
| B382SD907072090 | Surgical Direct | Surgical Direct, Inc. | 2026-07-27 |
| B382SD907072080 | Surgical Direct | Surgical Direct, Inc. | 2026-07-27 |
| B382SD9147096600 | Surgical Direct | Surgical Direct, Inc. | 2026-07-27 |
| B382SD9147096610 | Surgical Direct | Surgical Direct, Inc. | 2026-07-27 |
| 00850088713176 | PRINCETON | Princeton Medical Group, Inc. | 2026-07-23 |
| 00840183531232 | BR Surgical, LLC | BR Surgical, LLC | 2026-07-21 |
| B382SD907505200 | Surgical Direct | Surgical Direct, Inc. | 2026-07-17 |
| B382SD907505210 | Surgical Direct | Surgical Direct, Inc. | 2026-07-17 |
| 00190776395674 | Millennium | Avalign Technologies, Inc. | 2026-07-14 |
| 00810158216136 | PRINCETON | Princeton Medical Group, Inc. | 2026-06-23 |
| B7685252430 | Buxton BioMedical | Buxton Biomedical Inc | 2026-06-05 |
| 00810055258734 | Surgical Design | Surgical Design, Inc. | 2026-05-29 |
| 00810055258741 | Surgical Design | Surgical Design, Inc. | 2026-05-29 |
| 00810055258758 | Surgical Design | Surgical Design, Inc. | 2026-05-29 |
| B356FF192040 | American Medicals | American Medicals | 2022-09-26 |
| B35645724070 | American Medicals | American Medicals | 2022-09-09 |
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