Oscillating Knife and Accessories
FDA 510(k) K781412 · Codman & Shurtleff, Inc.
510(k) numberK781412
Submission
- Device name
- Oscillating Knife and Accessories
- Applicant
- Codman & Shurtleff, Inc.
Mchenry, IL, US - Received
- August 15, 1978
- Decision date
- October 11, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HMY – Keratome, Battery-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4370
- Specialty
- Ophthalmic
Other 510(k)s with product code HMY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040297 | Oneuse- Plus MicrokeratomeHMY · Traditional | Moria SA | 03/31/2004SE |
| K023092 | BD K-4000 Microkeratome SystemHMY · Special | Becton, Dickinson & CO | 10/18/2002SE |
| K022637 | BD-3000 Microkeratome System, Model K-3000 MicrokeratomeHMY · Traditional | Becton, Dickinson & CO | 10/16/2002SE |
| K022560 | M2 Single Use MicrokertomeHMY · Traditional | Moria SA | 09/27/2002SE |
| K003594 | Carriazo Barraquer Single Use MicrokeratomeHMY · Traditional | Moria, Inc. | 03/09/2001SE |
| K002191 | Carriazo Barraquer II MicrokeratomeHMY · Traditional | Moria, Inc. | 10/12/2000SE |
| K992687 | Millenium Microkeratome, Model IMD-001HMY · Traditional | Industrial & Medical Design, Inc. | 09/24/1999SE |
| K984537 | Keratome System, Model K3000HMY · Traditional | Insight Technologies Instruments, LLC | 05/14/1999SE |
| K981741 | Carriazo Barraquer MicrokeratomeHMY · Traditional | Moria, Inc. | 07/24/1998SE |
| K974243 | Keratome SystemHMY · Traditional | Insight Technologies Instruments, LLC | 01/20/1998SE |
More from Insight Technologies Instruments, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetNRY · Traditional | 07/20/2020SE |
| K191237 | CERENOVUS Large Bore CatheterDQY · Traditional | 11/08/2019SE |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP…GWM · Special | 11/08/2017SE |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System…JXG · Traditional | 10/16/2017SE |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)JXG · Traditional | 10/03/2017SE |
| K171862 | GALAXY G3 Mini Microcoil Delivery SystemHCG · Traditional | 09/25/2017SE |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…HCG · Special | 07/14/2017SE |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpDQY · Special | 07/03/2017SE |
| K162563 | YOGA MicrocatheterDQY · Special | 01/05/2017SE |
| K162437 | Codman EDS3 CSF External Drainage SystemJXG · Traditional | 10/28/2016SE |
Questions and answers
When was Oscillating Knife and Accessories cleared by the FDA?
Oscillating Knife and Accessories (K781412) received a 510(k) decision of Substantially Equivalent on October 11, 1978, 57 days after the submission was received.
What is the product code of K781412?
The FDA product code is HMY – Keratome, Battery-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.