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FDA 510(k)

LOTUS Series 4 Enhanced Shears, LOTUS Series 5

K-Number: K221102 · 2022-12-15

Decision Date2022-12-15
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

LOTUS Series 4 Enhanced Shears, LOTUS Series 5 is the device name listed in this FDA 510(k) record. The listed applicant is Sra Developments, Ltd.. It received FDA 510(k) clearance on 2022-12-15 under 510(k) number K221102. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOTUS Series 4 Enhanced Shears, LOTUS Series 5?

LOTUS Series 4 Enhanced Shears, LOTUS Series 5 is a medical device that received FDA 510(k) clearance on 2022-12-15. The listed applicant is Sra Developments, Ltd.. The 510(k) number is K221102.

When did LOTUS Series 4 Enhanced Shears, LOTUS Series 5 receive FDA 510(k) clearance?

LOTUS Series 4 Enhanced Shears, LOTUS Series 5 received FDA 510(k) clearance on 2022-12-15, under 510(k) number K221102.

Who is the listed applicant for LOTUS Series 4 Enhanced Shears, LOTUS Series 5?

The FDA 510(k) record lists Sra Developments, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOTUS Series 4 Enhanced Shears, LOTUS Series 5?

The FDA product code for LOTUS Series 4 Enhanced Shears, LOTUS Series 5 is LFL.

Related Devices (Code: LFL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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