LOTUS Series 4 Enhanced Shears, LOTUS Series 5— 510(k) K221102

Name: FDA 510(k) clearance K221102
Creator: U.S. Food and Drug Administration
Published: 2022-12-15

Substantially Equivalent

Sra Developments, Ltd.

FDA 510(k) clearance K221102 for LOTUS Series 4 Enhanced Shears, LOTUS Series 5, Substantially Equivalent on 2022-12-15. Applicant: Sra Developments, Ltd.. Device class: Unclassified.

Clearance details

Applicant: Sra Developments, Ltd.
Product code: Code LFL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2022-04-14
Decision date: 2022-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashburton, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Sra Developments, Ltd.

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K151101 — Lotus Series 4 Ultrasonic Surgical System & Accessories2015-07-17
K072961 — LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)2007-12-19
K063531 — SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM2007-02-22
K032424 — LOTUS2003-12-16

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.