Omnisonic Endoscopic Deflector
FDA 510(k) K993445 · Omnisonics Medical Technologies
510(k) numberK993445
Submission
- Device name
- Omnisonic Endoscopic Deflector
- Applicant
- Omnisonics Medical Technologies
Hopkonton, MA, US - Received
- October 12, 1999
- Decision date
- December 6, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCM – Endoscope, Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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| K083840 | Msi Medserv International-Rigid EndoscopeGCM · Traditional | Msi Medserv International Deutschland GmbH | 09/28/2009SE |
| K001217 | Inside ViewGCM · Traditional | Monadnock Optics, Inc. | 07/11/2000SE |
| K993103 | ENDOSCOPES,10MM Diameter 0 Degrees; Endoscopes, 10MM Diameter, 30 Degrees; Endoscopes…GCM · Traditional | Richard Wolf Medical Instruments Corp. | 12/10/1999SE |
| K962393 | Ksea Set for Endoscopic Assisted IntubationGCM · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/17/1996SE |
| K950712 | Portable Endoscopy SystemGCM · Traditional | Laser-Optik-Systeme GmbH & Co. KG | 05/14/1996SE |
| K955120 | Hand-Held Retractor, Dissector & DissectorGCM · Traditional | Ethicon Endo-Surgery, Inc. | 01/26/1996SE |
| K935235 | Endoscopy System for Facial Plastic SurgeryGCM · Traditional | Smith & Nephew Richards, Inc. | 03/23/1995SE |
| K945889 | Karl Storz Plastic Surgery AccessoriesGCM · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/22/1995SE |
| K931954 | Thoracoscope/LaparoscopeGCM · Traditional | Surgical Technologies, Inc. | 11/02/1993SE |
More from Surgical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K083335 | Modified Omniwave Endovascular SystemQEY · Special | 12/15/2008SE |
| K071762 | Omniwave Endovascular SystemQEY · Traditional | 09/27/2007SE |
| K052428 | Resolution Endovascular SystemQEY · Traditional | 12/08/2005SE |
| K041705 | Resolution Thrombectomy System, Model EV-2QEY · Traditional | 09/01/2004SE |
| K003824 | Omnisonics Ultrasonic Surgery System, Model StiLFL · Traditional | 03/08/2001SE |
| K993628 | Omnisonics Ultrasonic ProbesLFL · Traditional | 12/15/1999SE |
| K991377 | Omnisonics Flexible Fiber Optic Endoscope and CouplerGCJ · Traditional | 07/12/1999SE |
Questions and answers
When was Omnisonic Endoscopic Deflector cleared by the FDA?
Omnisonic Endoscopic Deflector (K993445) received a 510(k) decision of Substantially Equivalent on December 6, 1999, 55 days after the submission was received.
What is the product code of K993445?
The FDA product code is GCM – Endoscope, Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.