BTL-785NEH— 510(k) K253750
Substantially EquivalentBTL Industries, Inc.
FDA 510(k) clearance K253750 for BTL-785NEH, Substantially Equivalent on 2026-03-17. Applicant: BTL Industries, Inc.. Device class: 2.
Summary
BTL Industries' BTL-785NEH is filed under GEI, electrosurgical cutting and coagulation devices and accessories. The record gives only that model-style name and doesn't describe the device further.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
BTL Industries filed from Marlborough, Massachusetts. The decision came 112 calendar days after receipt (November 25, 2025 to March 17, 2026).
Clearance details
- Applicant
- BTL Industries, Inc.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
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More clearances from BTL Industries, Inc.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.