KARL STORZ SUPRALOOP— 510(k) K254303
Substantially EquivalentKarl Storz SE & CO. KG
FDA 510(k) clearance K254303 for KARL STORZ SUPRALOOP, Substantially Equivalent on 2026-09-24. Applicant: Karl Storz SE & CO. KG. Device class: 2.
Summary
The KARL STORZ SUPRALOOP is filed under KNF, unipolar endoscopic coagulator-cutters and accessories. The record doesn't describe its design or the procedures it's meant for.
Class II, 21 CFR 884.4160. The Obstetrics/Gynecology panel reviewed it as a Traditional 510(k).
Karl Storz SE & Co. KG filed from Tuttlingen. The record's location fields don't line up: "DE" sits in the state field and the country code reads US. The clock ran 267 days (December 31, 2025 to September 24, 2026).
Clearance details
- Applicant
- Karl Storz SE & CO. KG
- Product code
- Product code KNF
- Device class
- Class 2
- Regulation
- 21 CFR 884.4160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tuttlingen, DE, US
Recent devices under product code KNF
view all- K250705 — Sonata Transcervical Fibroid Ablation System 2.2
- K240503 — Sonata Transcervical Fibroid Ablation System 2.2
- K233848 — Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
- K222304 — Sonata Transcervical Fibroid Ablation System 2.2
- K211535 — Sonata Transcervical Fibroid Ablation System 2.2
More clearances from Karl Storz SE & CO. KG
view allData sourced from openFDA. This site is unofficial and independent of the FDA.