Endoscopy System for Facial Plastic Surgery
FDA 510(k) K935235 · Smith & Nephew Richards, Inc.
510(k) numberK935235
Submission
- Device name
- Endoscopy System for Facial Plastic Surgery
- Applicant
- Smith & Nephew Richards, Inc.
Bartlett, TN, US - Received
- November 1, 1993
- Decision date
- March 23, 1995
- 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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| K203226 | Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL…GCM · Traditional | Richard Wolf Medical Instruments Corporation | 05/14/2021SE |
| 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 |
| K993445 | Omnisonic Endoscopic DeflectorGCM · Traditional | Omnisonics Medical Technologies | 12/06/1999SE |
| 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 |
| 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 |
|---|---|---|
| K965224 | Empower Anterior Direct ScrewsKWP · Traditional | 05/08/1997SE |
| K963509 | Global Taper Tapered Hip System, GT SpectronLPH · Traditional | 01/27/1997SE |
| K960444 | Finn Rod to Rod ConnectorKWP · Traditional | 01/24/1997SE |
| K964163 | Trimax Nail SystemHSB · Traditional | 12/27/1996SE |
| K962557 | Genesis II Zirconium Femoral Component/Profix Zirconium Femoral ComponentJWH · Traditional | 12/05/1996SN |
| K963486 | Revision Hip SystemJDI · Traditional | 11/27/1996SE |
| K962541 | Reflection Acetabular Reinforcement RingsJDJ · Traditional | 09/17/1996SE |
| K962808 | Ilizarov External Fixation SystemKTT · Traditional | 08/19/1996SE |
| K962137 | Genesis II Constrained SystemJWH · Traditional | 08/02/1996SE |
| K955767 | Cofied Modular Shoulder SystemKWS · Traditional | 04/08/1996SN |
Questions and answers
When was Endoscopy System for Facial Plastic Surgery cleared by the FDA?
Endoscopy System for Facial Plastic Surgery (K935235) received a 510(k) decision of Substantially Equivalent on March 23, 1995, 507 days after the submission was received.
What is the product code of K935235?
The FDA product code is GCM – Endoscope, Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.