Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) 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. The listed applicant is Guangdong Optomedic Technologies, Inc.. The 510(k) number is K252318.

When did Insufflator (OPTO-IFL1000) receive FDA 510(k) clearance?

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

Who is the listed applicant for Insufflator (OPTO-IFL1000)?

The FDA 510(k) record lists Guangdong Optomedic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Guangdong Optomedic Technologies, Inc. as applicant

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.

K2526973D LaparoscopeK242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)K241530Stellar Imaging SystemK231342Insufflator (OPTO-IFL1000)K230407FloNavi Open Field Fluorescence Imaging SystemK231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)

View all 9 devices →

Related Devices (Code: HIF)

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.

K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems CorporationK242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona GroupK232902EVA15 insufflatorPalliare , Ltd.

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.

↑