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FDA 510(k)

HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR

K-Number: K905495 · 1991-04-29

ApplicantFrigitronics, Inc.
Decision Date1991-04-29
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Frigitronics, Inc.. It received FDA 510(k) clearance on 1991-04-29 under 510(k) number K905495. 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 HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR?

HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR is a medical device that received FDA 510(k) clearance on 1991-04-29. The listed applicant is Frigitronics, Inc.. The 510(k) number is K905495.

When did HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR receive FDA 510(k) clearance?

HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR received FDA 510(k) clearance on 1991-04-29, under 510(k) number K905495.

Who is the listed applicant for HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR?

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

What is the FDA product code for HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR?

The FDA product code for HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR is HIG.

Related Clinical Trials

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.

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Other records listing Frigitronics, 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.

K905392HT4-SERIES HYSTEROSCOPES AND ACCESSORIESK905393HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR

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

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