Carrier, Sponge, Endoscopic
The Endoscopic Sponge Carrier is an accessory used during endoscopic procedures to transport and deploy small sponges or gauze within body cavities for purposes such as hemostasis or tissue cleaning. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FGS, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- FGS
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
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 |
|---|---|---|---|---|
| K933604 | QB II BLUNT DISSECTOR | Sep 23, 1993 | Substantially Equivalent | Joyce M. Shotwell, M.D. |
| K931854 | ENDOSCOPIC BLUNT DISSECTING INSTRUMENT | Aug 10, 1993 | Substantially Equivalent | Mayaguez Medical Center |
| K923818 | O.R. CONCEPTS' IRRIGATING KITTNER | Apr 07, 1993 | Substantially Equivalent | O.R. Concepts, Inc. |
| K822194 | ENDOSCOPIC SPONGE CARRIER | Aug 27, 1982 | Substantially Equivalent | Kelleher Corp. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.