Inside View
FDA 510(k) K001217 · Monadnock Optics, Inc.
510(k) numberK001217
Submission
- Device name
- Inside View
- Applicant
- Monadnock Optics, Inc.
Huntingdon Valley, PA, US - Received
- April 17, 2000
- Decision date
- July 11, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GCM – Endoscope, Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GCM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
Questions and answers
When was Inside View cleared by the FDA?
Inside View (K001217) received a 510(k) decision of Substantially Equivalent on July 11, 2000, 85 days after the submission was received.
What is the product code of K001217?
The FDA product code is GCM – Endoscope, Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.