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FDA 510(k)

GYN-1500 HYSTEROSCOPIC INUFFLATOR

K-Number: K905706 · 1991-02-28

ApplicantCircon Acmi
Decision Date1991-02-28
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYN-1500 HYSTEROSCOPIC INUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Circon Acmi. It received FDA 510(k) clearance on 1991-02-28 under 510(k) number K905706. 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 GYN-1500 HYSTEROSCOPIC INUFFLATOR?

GYN-1500 HYSTEROSCOPIC INUFFLATOR is a medical device that received FDA 510(k) clearance on 1991-02-28. The listed applicant is Circon Acmi. The 510(k) number is K905706.

When did GYN-1500 HYSTEROSCOPIC INUFFLATOR receive FDA 510(k) clearance?

GYN-1500 HYSTEROSCOPIC INUFFLATOR received FDA 510(k) clearance on 1991-02-28, under 510(k) number K905706.

Who is the listed applicant for GYN-1500 HYSTEROSCOPIC INUFFLATOR?

The FDA 510(k) record lists Circon Acmi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GYN-1500 HYSTEROSCOPIC INUFFLATOR?

The FDA product code for GYN-1500 HYSTEROSCOPIC INUFFLATOR is HIG.

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Other records listing Circon Acmi 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.

K013165USA SERIES LAPAROSCOPESK980492AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)K905705LAP 3501 HIGH FLOW INSUFFLATORK884097MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPESK884025CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200K884254CIRCON ACMI BICAP III THERAPEUTIC SYSTEM

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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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