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FDA 510(k)

LM-100/200LOW FLOW INSUFFLATOR

K-Number: K912789 · 1991-09-20

ApplicantLeisegang Medical, Inc.
Decision Date1991-09-20
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LM-100/200LOW FLOW INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Leisegang Medical, Inc.. It received FDA 510(k) clearance on 1991-09-20 under 510(k) number K912789. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LM-100/200LOW FLOW INSUFFLATOR?

LM-100/200LOW FLOW INSUFFLATOR is a medical device that received FDA 510(k) clearance on 1991-09-20. The listed applicant is Leisegang Medical, Inc.. The 510(k) number is K912789.

When did LM-100/200LOW FLOW INSUFFLATOR receive FDA 510(k) clearance?

LM-100/200LOW FLOW INSUFFLATOR received FDA 510(k) clearance on 1991-09-20, under 510(k) number K912789.

Who is the listed applicant for LM-100/200LOW FLOW INSUFFLATOR?

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

What is the FDA product code for LM-100/200LOW FLOW INSUFFLATOR?

The FDA product code for LM-100/200LOW FLOW INSUFFLATOR is HIG.

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Other records listing Leisegang Medical, 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.

K990043SMOOTHLASE ALEXANDRITE LASER SYSTEMK940094COLPOSCOPES AND ACCESSORIESK924134LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESSK920217MAX-E-VACK914201LM- LAP 10 HIGH FLOW INSUFFLATORK913135LM-300TWIN

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Related Devices (Code: HIG)

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.

K261706Endomat Select (UP220)KARL STORZ SE & CO. KGK251273Asurys Fluid Management SystemBoston Scientific CorporationK240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K210628X-FLO Fluid Management SystemThermedx, LLCK201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KGK180735Endomat SelectKarl Storz SE & CO. KG

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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