Product code HND
- Device name
- Spatula, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4350
- Review panel
- OP
- 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 |
|---|---|---|---|
| K863990 | THORNTON TITANIUM SILVER SPATULA | Keeler Instruments, Inc. | 1986-10-31 |
| K810937 | ANIS IRRIGATING SPATULA | American V. Mueller | 1981-05-15 |
| K801609 | MADDOX LENS SPATULA CAT. #7245 | Edward Weck, Inc. | 1980-08-13 |
| K801608 | MCCULLEY CONTINUOUS SUTURE TIGHTNER | Edward Weck, Inc. | 1980-08-12 |
| K791983 | SPATULA'S #'S 7618,7248,7240,7242,5108 | Edward Weck, Inc. | 1979-10-04 |
| K761253 | CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM | Edward Weck, Inc. | 1976-12-16 |
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| G346EP203R0 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2025-11-05 |
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| G346EPV060 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2025-06-26 |
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| 08052276020574 | Delamination Spatula 27G | AKTIVE SRL | 2024-01-11 |
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| 08052276020529 | Retinal Pic 25G | AKTIVE SRL | 2024-01-11 |
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