FDA 510(k)

THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR

K-Number: K912498 · 1991-12-18

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1991-12-18

Product CodeHIG

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K912498. 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 THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR?

THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K912498.

When did THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR receive FDA 510(k) clearance?

THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR received FDA 510(k) clearance on 1991-12-18, under 510(k) number K912498.

Who is the listed applicant for THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR?

The FDA product code for THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

K252624KARL STORZ Laryngoscopes and Accessories K240506KARL STORZ Holders K223885HOPKINS Telescopes K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII System K223923HOPKINS Telescopes

View all 355 devices →

Related Devices (Code: HIG)

K261706Endomat Select (UP220)KARL STORZ SE & CO. KG K251273Asurys Fluid Management SystemBoston Scientific Corporation K240886Fluent 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, LLC K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG K180735Endomat 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.