Beaver Micro-Gem Gauge Block
FDA 510(k) K860305 · Rudolph Beaver, Inc.
510(k) numberK860305
Submission
- Device name
- Beaver Micro-Gem Gauge Block
- Applicant
- Rudolph Beaver, Inc.
Waltham, MA, US - Received
- January 28, 1986
- Decision date
- February 12, 1986
- 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 |
|---|---|---|
| K883361 | Arthro-Trac(Tm)HRX · Traditional | 10/13/1988SE |
| K875030 | OCU-1HMX · Traditional | 05/03/1988SE |
| K862709 | Mechanical CystitomeHNY · Traditional | 08/01/1986SE |
| K852828 | Beaver R-K KnifeHNN · Traditional | 11/04/1985SN |
| K853129 | Beaver Multipurpose Sapphire KnifeHNN · Traditional | 08/06/1985SE |
Questions and answers
When was Beaver Micro-Gem Gauge Block cleared by the FDA?
Beaver Micro-Gem Gauge Block (K860305) received a 510(k) decision of Substantially Equivalent on February 12, 1986, 15 days after the submission was received.
What is the product code of K860305?
The FDA product code is HNN – Knife, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.