Corneal Scleral Lance
FDA 510(k) K840855 · Sharpoint, Inc.
510(k) numberK840855
Submission
- Device name
- Corneal Scleral Lance
- Applicant
- Sharpoint, Inc.
Walker, MI, US - Received
- February 24, 1984
- Decision date
- May 9, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNN – Knife, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110166 | Clearcut S Safety KnifeHNN · Abbreviated | Alcon Research, Ltd. | 05/20/2011SE |
| K922378 | Ophthalmic KnifeHNN · Traditional | Microptics Development Laboratory | 12/10/1992SE |
| K882402 | Retractive Incision Micrometer (Rim) GuageHNN · Traditional | Optical Center | 08/22/1988SE |
| K881669 | Mvr/Stiletto Blade 20GA. - P/N 1900HNN · Traditional | Advanced Surgical Products, Inc. | 05/13/1988SE |
| K874979 | Prisma Disposable Mvr/Stiletto BladeHNN · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874057 | Ophthalmic Tip & Blade ScalpelsHNN · Traditional | Myocure, Inc. | 12/23/1987SE |
| K874056 | Ophthalmic Disposable BladesHNN · Traditional | Myocure, Inc. | 12/22/1987SE |
| K873385 | Ophthalmic Phaco-BladeHNN · Traditional | Myocure, Inc. | 09/21/1987SE |
| K871285 | Knife, OphthalmicHNN · Traditional | Trueline Instruments, Inc. | 04/27/1987SE |
| K864290 | Rk-M & Rk-Dk Diamond Knives with Measuring GaugeHNN · Traditional | Keeler Instruments, Inc. | 12/15/1986SE |
More from Keeler Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K863595 | Coated Suture NeedleGAB · Traditional | 10/24/1986SE |
| K861947 | Surgical KnifeEMF · Traditional | 06/06/1986SE |
| K840764 | Ear KnivesJYO · Traditional | 05/21/1984SE |
| K840660 | Posterior Capsulotomy CystitomeHNY · Traditional | 03/16/1984SE |
| K840659 | Anterior Capsulectomy CystitomeHNY · Traditional | 03/16/1984SE |
| K830522 | Stainless Steel Suture 316L · Traditional | 03/31/1983SE |
| K822112 | Ophthalmic KnifeHNN · Traditional | 08/10/1982SE |
| K821440 | V LanceHNN · Traditional | 06/14/1982SE |
Questions and answers
When was Corneal Scleral Lance cleared by the FDA?
Corneal Scleral Lance (K840855) received a 510(k) decision of Substantially Equivalent on May 9, 1984, 75 days after the submission was received.
What is the product code of K840855?
The FDA product code is HNN – Knife, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.