Mvr/Stiletto Blade 20GA. - P/N 1900
FDA 510(k) K881669 · Advanced Surgical Products, Inc.
510(k) numberK881669
Submission
- Device name
- Mvr/Stiletto Blade 20GA. - P/N 1900
- Applicant
- Advanced Surgical Products, Inc.
Chesterfield, MO, US - Received
- April 18, 1988
- Decision date
- May 13, 1988
- 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 |
| 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 |
| K863725 | Cataract Diamond KnifeHNN · Traditional | Medical Technology Development Corp. | 10/31/1986SE |
More from Medical Technology Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K030926 | Fast Throw Stainless Steel Surgical SutureFZP · Traditional | 07/21/2003SE |
| K895800 | Advanced Surgical Solid State Bipolar CoagulatorHQR · Traditional | 01/22/1990SE |
| K896754 | I/A HandpieceHQE · Traditional | 01/11/1990SE |
| K896305 | Multi-Use I/A HandpieceHQE · Traditional | 12/18/1989SE |
| K884557 | Advanced Surgical Products Scissors HandpieceHQE · Traditional | 05/12/1989SE |
| K884556 | Dreyer Curved EndoilluminatorHQE · Traditional | 02/28/1989SE |
| K890398 | Ryan-Style Directed Infusion ManipulatorHBI · Traditional | 02/17/1989SE |
| K884347 | Modified Disposable Coaxial Bipolar PenGXI · Traditional | 12/27/1988SE |
| K883858 | Fiberoptic Sharp Integral Pick LightpipeHBI · Traditional | 09/29/1988SE |
| K883857 | Fiberoptic Wire Pick LightpipeHBI · Traditional | 09/29/1988SE |
Questions and answers
When was Mvr/Stiletto Blade 20GA. - P/N 1900 cleared by the FDA?
Mvr/Stiletto Blade 20GA. - P/N 1900 (K881669) received a 510(k) decision of Substantially Equivalent on May 13, 1988, 25 days after the submission was received.
What is the product code of K881669?
The FDA product code is HNN – Knife, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.