Esophagoscope, General & Plastic Surgery
The Esophagoscope, General and Plastic Surgery (product code GCL) is an endoscope used to visualize the esophagus for diagnostic or therapeutic purposes, such as identifying strictures, lesions, or foreign bodies, and may be used to perform interventional procedures. It is classified as FDA Class 2, requiring a 510(k) premarket notification. For reusable devices, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission, as required by 82 FR 26807. The device is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology specialty (GU).
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Basic Information
- Product Code
- GCL
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K951198 | FE-34TH, FIBER ESOPHAGOSCOPE | May 30, 1995 | Substantially Equivalent | Pentax Precision Instrument Corp. |
| K951197 | FE-24X, FIBER ESOPHAGOSCOPE | May 30, 1995 | Substantially Equivalent | Pentax Precision Instrument Corp. |
| K934510 | 5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD | Feb 17, 1994 | Substantially Equivalent | Phx Technologies Corp. |
| K922086 | BARD BIOPSY FORCEPS | Oct 30, 1992 | Substantially Equivalent | C.R. Bard, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.