Thornton Titanium Silver Spatula
FDA 510(k) K863990 · Keeler Instruments, Inc.
510(k) numberK863990
Submission
- Device name
- Thornton Titanium Silver Spatula
- Applicant
- Keeler Instruments, Inc.
Broomall, PA, US - Received
- October 14, 1986
- Decision date
- October 31, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HND – Spatula, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HND
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K810937 | Anis Irrigating SpatulaHND · Traditional | American V. Mueller | 05/15/1981SE |
| K801609 | Maddox Lens Spatula Cat. #7245HND · Traditional | Edward Weck, Inc. | 08/13/1980SE |
| K801608 | Mcculley Continuous Suture TightnerHND · Traditional | Edward Weck, Inc. | 08/12/1980SE |
| K791983 | Spatula's #'S 7618,7248,7240,7242,5108HND · Traditional | Edward Weck, Inc. | 10/04/1979SE |
| K761253 | Cyclodialysis Spat. 15MM Blade TitaniumHND · Traditional | Edward Weck, Inc. | 12/16/1976SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K181143 | Keeler TonoCare TonometerHKX · Traditional | 02/08/2019SE |
| K112093 | Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe AdapterHRN · Special | 12/08/2011SE |
| K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000HKX · Traditional | 12/10/2010SE |
| K100500 | PSL Classic Slit LampHJO · Traditional | 03/09/2010SE |
| K062412 | CryomaticHRN · Traditional | 11/06/2006SE |
| K060822 | Vantage Indirect OphthalmoscopeHLI · Special | 05/23/2006SE |
| K032087 | Keeler Wide Angle Ophthalmoscope Model 1130-P-5004HLJ · Traditional | 11/26/2003SE |
| K992954 | Keeler Cryo Master & ProbesHRN · Traditional | 12/21/1999SE |
| K990257 | Keeler Pulsair 3000 Non Contact TonometerHKX · Traditional | 03/25/1999SE |
| K973064 | Keeler Tearscope-PlusHJO · Traditional | 04/07/1998SE |
Questions and answers
When was Thornton Titanium Silver Spatula cleared by the FDA?
Thornton Titanium Silver Spatula (K863990) received a 510(k) decision of Substantially Equivalent on October 31, 1986, 17 days after the submission was received.
What is the product code of K863990?
The FDA product code is HND – Spatula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.