Product code GDI
- Device name
- Dissector, 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 |
|---|---|---|---|
| K896383 | DISPOSABLE EXTERNAL CLAMPS | Galenica Enterprises, Inc. | 1989-12-06 |
| K850288 | HEPATIC PARENCHYMAL SUCTION DISSECTOR | Beecher Medical Diagnostic Instrumentation | 1985-03-18 |
| K831912 | ROUND-BEEHIVE- DISSECTORS 3/8 | Ormed Mfg., Inc. | 1983-10-31 |
| K822569 | TYMPANOPLASTY & SKIN DISSECTORS | Kelleher Corp. | 1982-10-06 |
| K803292 | FIELD SUCTION DISSECTOR | V. Mueller O.V. Baxter Healthcare Corp. | 1981-01-29 |
| K791870 | DISPOSABLE SPECIALITY SPONGES | Carwild Corp. | 1979-11-05 |
| K791703 | TEW BYPASS INSTRUMENTS & DISSECTING KIT | Edward Weck, Inc. | 1979-10-04 |
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|---|---|---|---|
| 00190776435363 | Millennium | Avalign Technologies, Inc. | 2026-10-19 |
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| 00840217909372 | Ace Medical Company | EBNER MEDICAL, LLC | 2024-12-09 |
| 00840217909365 | Ace Medical Company | EBNER MEDICAL, LLC | 2024-12-09 |
| 00840217909358 | Ace Medical Company | EBNER MEDICAL, LLC | 2024-12-09 |
| 00840217906814 | Wiggins Medical | EBNER MEDICAL, LLC | 2022-08-25 |
| 00840217906807 | Wiggins Medical | EBNER MEDICAL, LLC | 2022-08-25 |
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| 00840217905664 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-10-26 |
| 00840217905459 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-07-14 |
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