Endoscope, Ac-Powered And Accessories
The Endoscope, AC-Powered And Accessories (product code GCP) is an alternating current-powered endoscope system, including associated accessories, used to provide illuminated visualization of internal body cavities or organs during gastroenterological or urological examinations and procedures. It is classified as FDA Class 2, requiring a 510(k) premarket notification demonstrating substantial equivalence. The device is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology specialty (GU). No special flags apply to this device.
Research product code GCP in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- GCP
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K954614 | EOS BRAND DISPOSABLE PROCTOSCOPE | Apr 10, 1996 | Substantially Equivalent | North Eos Industries, Inc. |
| K896505 | PORGES UNIVERSAL HANDLES | Jan 30, 1990 | Substantially Equivalent | Porges Corp. |
| K896008 | MODEL 6500 MERCURY ARC LIGHT SOURCE | Dec 27, 1989 | Substantially Equivalent | Medical Dynamics, Inc. |
| K862424 | STEERABLE CATHETER SYSTEM | Sep 22, 1986 | Substantially Equivalent | Endovations |
| K860103 | MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE | Feb 12, 1986 | Substantially Equivalent | Endotherapeutics |
| K843683 | MODULAR FIBERSCOPE SYSTEM | Jan 18, 1985 | Substantially Equivalent | Reichert Scientific Instruments |
| K833859 | TAMPONADE BALLOON CUFF | Jan 03, 1984 | Substantially Equivalent | American Endoscopy, Inc. |
| K821999 | ENDOSCOPIC SCLEROTHERAPY BALLOON | Aug 27, 1982 | Substantially Equivalent | Retech |
| K801247 | CCD ENDOSCOPE AND ATTACHMENTS | Jul 28, 1980 | Substantially Equivalent | Welch Allyn, Inc. |
| K790071 | ENDOSCOPE AND ACCESSORIES | Apr 02, 1979 | Substantially Equivalent | Olympus Corp. |
| K771920 | FIBER OPTICS PROCTOSCOPE | Oct 20, 1977 | Substantially Equivalent | Propper Mfg. Co., Inc. |
| K771919 | FIBER OPTICS SIGMOIDOSCOPE | Oct 20, 1977 | Substantially Equivalent | Propper Mfg. Co., Inc. |
| K771918 | FIBEO OPTICS ILLUM. SYSTEM | Oct 20, 1977 | Substantially Equivalent | Propper Mfg. Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.