Nagashima Su-A Ceiling Mount Unit for
FDA 510(k) K822014 · Kelleher Corp.
510(k) numberK822014
Submission
- Device name
- Nagashima Su-A Ceiling Mount Unit for
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- July 8, 1982
- Decision date
- August 6, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EPT – Microscope, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4700
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code EPT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942233 | MKM (Multiple Coordinate Manipulator) SystemEPT · Traditional | Carl Zeiss, Inc. | 07/01/1994SE |
| K931284 | Microdyne Office Surgical MicroscopeEPT · Traditional | Microdyne, Inc. | 11/18/1993SE |
| K933310 | Micrins Contrast Background MaterialEPT · Traditional | Micrins Surgical, Inc. | 08/19/1993SE |
| K903412 | Storz Model M705 And/Or M706 Ceiling Mounted Micr.EPT · Traditional | Storz Instrument Co. | 09/20/1990SE |
| K883581 | Opmi CSEPT · Traditional | Carl Zeiss, Inc. | 09/13/1988SE |
| K882269 | Storz Diagnostic Microscope SystemEPT · Traditional | Storz Instrument Co. | 06/23/1988SE |
| K860811 | Zeiss Voice Control System for Opmi'sEPT · Traditional | Carl Zeiss, Inc. | 04/30/1986SE |
| K844858 | Storz/Urban Surgical Microscope SystemEPT · Traditional | Storz Instrument Co. | 03/25/1985SE |
| K832887 | Electronic UnitEPT · Traditional | Surgi-Quip Inc.U | 10/04/1983SE |
| K823011 | VC IIIEPT · Traditional | Teknar, Inc. | 11/08/1982SE |
More from Teknar, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822618 | Emergency Tracheostomy Instrument SetLJW · Traditional | 01/28/1983SE |
| K822268 | Nagashima Ns-Iii ElectronystagmographGWN · Traditional | 01/28/1983SE |
| K823083 | Electrosurgical UnitGEI · Traditional | 12/07/1982SE |
| K823111 | Nystymograph AccessGNN · Traditional | 11/22/1982SE |
| K822252 | ENT Treatment UnitsETF · Traditional | 11/22/1982SE |
| K822272 | Head Mirrors W/Head Lamps & Head BandsHPQ · Traditional | 11/10/1982SE |
| K822017 | Tympanostomy Tubes & Various TypesETD · Traditional | 10/27/1982SE |
| K822257 | Various Types of Light Source HandlesEOQ · Traditional | 10/26/1982SE |
| K822259 | Laryngeal SpatulasEQH · Traditional | 10/22/1982SE |
| K822004 | Face ShieldsKNT · Traditional | 10/20/1982SE |
Questions and answers
When was Nagashima Su-A Ceiling Mount Unit for cleared by the FDA?
Nagashima Su-A Ceiling Mount Unit for (K822014) received a 510(k) decision of Substantially Equivalent on August 6, 1982, 29 days after the submission was received.
What is the product code of K822014?
The FDA product code is EPT – Microscope, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4700.