Disposable Endoilluminator
FDA 510(k) K923774 · O.R. Specialties, Inc.
510(k) numberK923774
Submission
- Device name
- Disposable Endoilluminator
- Applicant
- O.R. Specialties, Inc.
Tuscaloosa, AL, US - Received
- July 28, 1992
- Decision date
- October 19, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EQH – Source, Carrier, Fiberoptic Light
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4350
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EQH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945876 | Weco Endoscopic System with Fiber Optic LightEQH · Traditional | Wells Johnson Co. | 12/04/1995SE |
| K954184 | Jed-Light Fiberoptic Light SourceEQH · Traditional | Jedmed Instrument Co. | 11/13/1995SE |
| K951829 | Cold Light Source Los 150EQH · Traditional | Laser-Optik-Systeme GmbH & Co. KG | 07/10/1995SE |
| K932771 | Battery Powered, Disposable Endoscope Light SourceEQH · Traditional | Xomed-Treace, Inc. | 08/24/1994SE |
| K941661 | GM Opti*Cam Camer with Dental Fiber Optic LightEQH · Traditional | Gm Engineering, Inc. | 08/23/1994SE |
| K941662 | GM Opti*Cam Camera with ENT Fiber Optic LightEQH · Traditional | Gm Engineering, Inc. | 07/20/1994SE |
| K934911 | Saphire Plus Surgical MirrorEQH · Traditional | San Diego Swiss Machining, Inc. | 06/21/1994SE |
| K932131 | Mid Labs Twin IlluminatorEQH · Traditional | Medical Instrument Development Laboratories, Inc. | 04/01/1994SE |
| K930123 | Aspirating Endo Ocular ProbeEQH · Traditional | Surgical Technologies, Inc. | 02/16/1994SE |
| K933145 | Fiberoptic Lightsources and CarriersEQH · Traditional | Electro Fiberoptics Corp. | 09/07/1993SE |
More from Electro Fiberoptics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K942607 | Laparoscopic Scissors (Disposable)GEI · Traditional | 07/06/1994SE |
| K923630 | Phaco Needles 1000-R & 1000-O NeedlesHQC · Traditional | 04/06/1994SE |
| K925671 | Disposable Scleral PlugsLXP · Traditional | 08/02/1993SE |
| K923887 | Jack's Vent TubesETD · Traditional | 02/19/1993SE |
| K922355 | Polly's Vitreous Scissors J-225-SHQE · Traditional | 08/18/1992SE |
| K922180 | Lewicky O.R.S. TubingKYG · Traditional | 07/02/1992SE |
| K914038 | Polly's Cutter J-225HQE · Traditional | 12/09/1991SE |
| K911932 | J105 James Surgical System I/A PackGZX · Traditional | 08/26/1991SE |
| K890195 | James Surgical System J1000HQE · Traditional | 08/03/1989SE |
| K891161 | Vitrectomy Pack #J120HQC · Traditional | 05/26/1989SE |
Questions and answers
When was Disposable Endoilluminator cleared by the FDA?
Disposable Endoilluminator (K923774) received a 510(k) decision of Substantially Equivalent on October 19, 1992, 83 days after the submission was received.
What is the product code of K923774?
The FDA product code is EQH – Source, Carrier, Fiberoptic Light, a Class I (low risk) device regulated under 21 CFR 874.4350.