Hot Biopsy Forceps Feenestrated 230 Cm Oval Cup, Hot Biopsy Forceps Serrated 16…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K992390 FDA 510(k)
- FDA Product Code
- KGE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4300 FDA 510(k)
- Regulation Number
- 876.4300 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hot Biopsy Forceps are electric biopsy forceps designed for tissue sampling and polyp removal during endoscopic procedures. These instruments feature oval cups and are available in fenestrated or serrated configurations to facilitate precise tissue collection and cauterization.
These devices are intended for use in gastroenterology and urology settings. The forceps are available in various lengths, including 160 cm and 230 cm models, and have received FDA 510(k) clearance.
Frequently asked questions
What are the TeleMed Hot Biopsy Forceps used for?
These electric forceps are designed for tissue sampling and polyp removal during endoscopic procedures. They are intended for use by clinicians in gastroenterology and urology settings to facilitate precise tissue collection and cauterization.
What configurations are available for these forceps?
The forceps feature oval cups and are available in either fenestrated or serrated configurations. They are also provided in different lengths, specifically 160 cm and 230 cm models, to accommodate various procedural requirements.
What is the regulatory status of these devices?
These devices have received FDA 510(k) clearance. This indicates that the manufacturer has demonstrated the device is substantially equivalent to a legally marketed predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hot Biopsy Forceps - Hot Forceps | Micro-Tech Endoscopy, (HOT) Biopsy Forceps - medi-globe.de, ConMed Precisor Hot Biopsy Forceps - 2.3 mm × 230 cm, Hot Biopsy Forceps Feenestrated 230 Cm Oval Cup, Hot Biopsy Forceps ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K992390 | Class II | Active |
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Manufacturer
- Manufacturer
- TeleMed Systems
- FDA Applicant
- Telemed Systems, Inc.
Sources (1)
- FDA 510(k) K992390 24 fields · synced Oct 6, 2026