Blade Gauge
FDA 510(k) K812011 · Koi, Inc.
510(k) numberK812011
Submission
- Device name
- Blade Gauge
- Applicant
- Koi, Inc.
Mchenry, IL, US - Received
- July 17, 1981
- Decision date
- July 28, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOE – Caliper, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HOE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881094 | Koi(Tm) Blade Gauge, Model KOI-132HOE · Traditional | CooperVision, Inc. | 04/01/1988SE |
| K813315 | Caliper-OpthalmicHOE · Traditional | Design Research Assoc., Inc. | 03/01/1982SE |
| K820050 | Kremer Blade GaugeHOE · Traditional | Accutome, Inc. | 02/24/1982SE |
| K801937 | BlepharometerHOE · Traditional | Aztec Medical Products, Inc. | 09/16/1980SE |
| K792383 | Kelman DipstickHOE · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 12/11/1979SE |
| K781715 | Ruler, Weck ScottHOE · Traditional | Edward Weck, Inc. | 12/04/1978SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843247 | Koi PachymeterITX · Traditional | 04/30/1986SE |
| K830366 | Diamond KnifeHNN · Traditional | 03/09/1983SE |
| K812764 | Koi Blue Field EntoptoscopeHKL · Traditional | 12/02/1981SE |
| K812450 | Koi Diamond KnifeHNN · Traditional | 09/21/1981SE |
| K812097 | Koi Lacremal Hook & DilatorHNW · Traditional | 08/18/1981SE |
| K812010 | Koi Lacrimal Intubation SystemHMX · Traditional | 07/28/1981SE |
Questions and answers
When was Blade Gauge cleared by the FDA?
Blade Gauge (K812011) received a 510(k) decision of Substantially Equivalent on July 28, 1981, 11 days after the submission was received.
What is the product code of K812011?
The FDA product code is HOE – Caliper, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.