Binocular Oper. Microscopes & Accessor
FDA 510(k) K822181 · Kelleher Corp.
510(k) numberK822181
Submission
- Device name
- Binocular Oper. Microscopes & Accessor
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- July 23, 1982
- Decision date
- August 27, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FSO – Microscope, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4700
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942304 | MicroflexFSO · Traditional | Moeller Microsurgical, Inc. | 06/13/1994SE |
| K941399 | Operating Microscope Aa Om 10FSO · Traditional | Appasamy Associates (U.S.A.), Inc. | 04/22/1994SE |
| K920689 | Deemed MSS -- Microscope Support SystemFSO · Traditional | Deemed, Inc. | 11/12/1993SE |
| K926288 | Som 6VI (Surgical Operating Microscope)FSO · Traditional | Jedmed Instrument Co. | 10/12/1993SE |
| K931303 | Woodlyn Operation MicroscopeFSO · Traditional | Woodlyn, Inc. | 06/25/1993SE |
| K926513 | Moller-Wedel Operating MicroscopeFSO · Traditional | Moeller Microsurgical, Inc. | 06/22/1993SE |
| K910357 | Som 6VFSO · Traditional | Jedmed Instrument Co. | 02/19/1991SE |
| K902076 | J2 MicroscopeFSO · Traditional | Jedmed Instrument Co. | 08/01/1990SE |
| K874241 | Opmi MD Surgical MicroscopeFSO · Traditional | Carl Zeiss, Inc. | 12/23/1987SE |
| K822562 | Odonto-ScopeFSO · Traditional | Treace Medical, Inc. | 10/06/1982SE |
More from Treace Medical, 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 Binocular Oper. Microscopes & Accessor cleared by the FDA?
Binocular Oper. Microscopes & Accessor (K822181) received a 510(k) decision of Substantially Equivalent on August 27, 1982, 35 days after the submission was received.
What is the product code of K822181?
The FDA product code is FSO – Microscope, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4700.