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FDA 510(k)

Insufflator (OPTO-IFL1000)

K-Number: K252318 · 2026-04-16

ApplicantGuangdong Optomedic Technologies, Inc.
Decision Date2026-04-16
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Insufflator (OPTO-IFL1000) is a medical device manufactured by Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2026-04-16 under approval number K252318. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Insufflator (OPTO-IFL1000)?

Insufflator (OPTO-IFL1000) is a medical device that received FDA 510(k) clearance on 2026-04-16. It is manufactured by Guangdong Optomedic Technologies, Inc.. The 510(k) number is K252318.

When was Insufflator (OPTO-IFL1000) approved by the FDA?

Insufflator (OPTO-IFL1000) received FDA 510(k) clearance on 2026-04-16, under approval number K252318.

What company makes Insufflator (OPTO-IFL1000)?

Insufflator (OPTO-IFL1000) is manufactured by Guangdong Optomedic Technologies, Inc..

What is the FDA product code for Insufflator (OPTO-IFL1000)?

The FDA product code for Insufflator (OPTO-IFL1000) is HIF.

Other Devices by Guangdong Optomedic Technologies, Inc.

K231342Insufflator (OPTO-IFL1000) K230407FloNavi Open Field Fluorescence Imaging System K231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) K221861FloNavi Endoscopic Fluorescence Imaging System K221781Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH K242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)

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Related Devices (Code: HIF)

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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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