Endoscope, Battery-Powered And Accessories
The Endoscope, Battery-Powered And Accessories (product code GCS) is a battery-operated endoscope with associated accessories, providing a portable, self-contained illuminated visualization system for inspecting internal body cavities or organs in gastroenterological and urological settings. It is classified as FDA Class 2, requiring a 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The device is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology specialty (GU). No special flags apply to this device.
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Basic Information
- Product Code
- GCS
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K944062 | LAPRASCOPIC GRASPER | Feb 23, 1995 | Substantially Equivalent | Instrument Makar, Inc. |
| K944067 | PEANUT WAND, MODIFICATION | Dec 08, 1994 | Substantially Equivalent | Ideal Medical, Inc. |
| K933201 | AESCULAP TROCAR INSTRUMENT SET | Sep 13, 1993 | Substantially Equivalent | Aesculap, Inc. |
| K932762 | 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT | Aug 31, 1993 | Substantially Equivalent | Inman Medical Corp. |
| K933371 | IMC ENDOSCOPIC INSTRUMENT HOLDER | Aug 06, 1993 | Substantially Equivalent | Inman Medical Corp. |
| K924134 | LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS | Jul 02, 1993 | Substantially Equivalent | Leisegang Medical, Inc. |
| K931340 | GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR | Jul 01, 1993 | Substantially Equivalent | Baxter Healthcare Corp |
| K925276 | M.I.S. TROCAR-CANNULA | May 24, 1993 | Substantially Equivalent | M.I.S. Technology, Inc. |
| K921006 | LAPAROSCOPIC RETRACTOR SYSTEM | Jul 28, 1992 | Substantially Equivalent | Laparomed Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.