Identifiers
- 510(k) Number
- K230467 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BTL-899F is a Class II electrosurgical cutting and coagulation device and accessories, as defined by regulation number 21 CFR 878.4400 and product code GEI. It is a general and plastic surgery device that received FDA 510(k) clearance through the traditional pathway.
The device was cleared on September 21, 2023, under K230467, following a 212-day review. It is manufactured by BTL Industries, Inc. at 362 Elm St., Marlborough, MA 01752. No information is provided regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or clinical indications for use.
Frequently asked questions
What is the BTL-899F used for?
The BTL-899F is a Class II electrosurgical cutting and coagulation device intended for use in general and plastic surgery procedures, as defined by its FDA 510(k) clearance under product code GEI and regulation 21 CFR 878.4400.
How was the BTL-899F cleared for market?
The BTL-899F received FDA 510(k) clearance through the traditional pathway on September 21, 2023, under submission number K230467, following a 212-day review period after being received on February 21, 2023.
Who manufactures the BTL-899F and where is it made?
The BTL-899F is manufactured by BTL Industries, Inc. at their facility located at 362 Elm St., Marlborough, MA 01752, United States, as specified in the device’s authorization records.
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: K230467 FDA 510 (k) - BTL-899F | BTL Industries, Inc., PDF September 21, 2023 David Chmel VP of Operations, PDF K230467 - Btl-899f, BTL-899F — FDA 510 (k) K230467 | MedTracker - aiqixie.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230467 | Class II | Active |
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Manufacturer
- Manufacturer
- BTL Industries, Inc.
Sources (1)
- FDA 510(k) K230467 24 fields · synced Sep 28, 2026