Standard Endoscope
FDA 510(k) K972056 · Laser-Optik-Systeme GmbH & Co. KG
510(k) numberK972056
Submission
- Device name
- Standard Endoscope
- Applicant
- Laser-Optik-Systeme GmbH & Co. KG
Mainz, DE - Received
- June 2, 1997
- Decision date
- July 30, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K992540 | Xenon Light Source Pes 1GCT · Traditional | 09/14/1999SE |
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| K953419 | Los 3D Vision 100GCJ · Traditional | 02/08/1996SE |
| K952028 | Cold Light Source Los Xl-A 100GCT · Traditional | 07/27/1995SE |
| K951829 | Cold Light Source Los 150EQH · Traditional | 07/10/1995SE |
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Questions and answers
When was Standard Endoscope cleared by the FDA?
Standard Endoscope (K972056) received a 510(k) decision of Substantially Equivalent on July 30, 1997, 58 days after the submission was received.
What is the product code of K972056?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.