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FDA 510(k)

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen

K-Number: K213146 · 2023-10-27

ApplicantJiangsu Rongye Technology Co., Ltd.
Decision Date2023-10-27
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen is a medical device manufactured by Jiangsu Rongye Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-27 under approval number K213146. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen?

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by Jiangsu Rongye Technology Co., Ltd.. The 510(k) number is K213146.

When was Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen approved by the FDA?

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen received FDA 510(k) clearance on 2023-10-27, under approval number K213146.

What company makes Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen?

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen is manufactured by Jiangsu Rongye Technology Co., Ltd..

What is the FDA product code for Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen?

The FDA product code for Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen is JKA.

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 41322758 Real-World Case Series on Surgi-ORC® in ENT Surgery. Cureus (2025) PMID: 41085780 Evaluation of nickel release from Ni-Ti stents in various media for safety assessment purposes. Journal of materials science. Materials in medicine (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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