Xomed-Treace Rigid Rod Lens Endoscope
FDA 510(k) K933105 · Xomed-Treace, Inc.
510(k) numberK933105
Submission
- Device name
- Xomed-Treace Rigid Rod Lens Endoscope
- Applicant
- Xomed-Treace, Inc.
Jacksonville, FL, US - Received
- June 25, 1993
- Decision date
- January 5, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOB – Nasopharyngoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code EOB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261544 | Hydro Irrigation SystemEOB · Traditional | Stryker Instruments | 06/17/2026SE |
| K254133 | ENTity USB Videoscope SystemEOB · Traditional | Optim, LLC | 05/14/2026SE |
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…EOB · Traditional | Zhuhai Wesee Meditech Co., Ltd. | 03/25/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | Olympus Medical Systems Corporation | 03/20/2026SE |
| K241731 | Outlook Surgical Versa One System (8900139)EOB · Traditional | Resnent, LLC | 08/11/2025SE |
| K243639 | Portare System (FA-001)EOB · Traditional | Grumpy Innovation, Inc. | 06/05/2025SE |
| K243380 | Visera S Video System Center Olympus OTV-S500 (Olympus OTV-S500)EOB · Traditional | Olympus Medical Systems Corporation | 03/03/2025SE |
| K234096 | MonoStereoEOB · Traditional | Medicaltek Co., Ltd. | 09/19/2024SE |
| K232435 | Rhinolaryngoscope systemEOB · Traditional | Shenzhen HugeMed Medical Technical Development… | 04/26/2024SE |
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)EOB · Traditional | Atmos Medizintechnik GmbH & Co. KG | 08/03/2023SE |
More from Atmos Medizintechnik GmbH & Co. KG
| 510(k) | Device | Decision |
|---|---|---|
| K940028 | Endoscope SheathEOB · Traditional | 03/24/1995SE |
| K941407 | Tympanostomy (Ventilation) TubeETD · Traditional | 03/14/1995SE |
| K945659 | Blackstar(Tm) Star SystemERL · Traditional | 01/09/1995SE |
| K932771 | Battery Powered, Disposable Endoscope Light SourceEQH · Traditional | 08/24/1994SE |
| K933672 | Xomed-Treace ScopesheathEOB · Traditional | 07/18/1994SE |
| K934426 | Nerve Integrity MONITOR-2 (NIM-2 XL)ETN · Traditional | 05/13/1994SE |
| K925640 | Xomed-Treace Emg Endotracheal TubeenETN · Traditional | 08/17/1993SE |
| K922880 | Xomed Treace Jet Ventilation TubeBTR · Traditional | 04/15/1993SE |
| K923830 | Xomed-Treace AlphascopeERA · Traditional | 11/09/1992SE |
| K912753 | Xomed-Treace Positrol Footpedal Suction ControlGCX · Traditional | 09/23/1991SE |
Questions and answers
When was Xomed-Treace Rigid Rod Lens Endoscope cleared by the FDA?
Xomed-Treace Rigid Rod Lens Endoscope (K933105) received a 510(k) decision of Substantially Equivalent on January 5, 1994, 194 days after the submission was received.
What is the product code of K933105?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.