FDA 510(k)

KARL STORZ PLASTIC SURGERY ACCESSORIES

K-Number: K945889 · 1995-03-22

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1995-03-22

Product CodeGCM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

KARL STORZ PLASTIC SURGERY ACCESSORIES 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 1995-03-22 under 510(k) number K945889. The device is classified under product code GCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ PLASTIC SURGERY ACCESSORIES?

KARL STORZ PLASTIC SURGERY ACCESSORIES is a medical device that received FDA 510(k) clearance on 1995-03-22. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K945889.

When did KARL STORZ PLASTIC SURGERY ACCESSORIES receive FDA 510(k) clearance?

KARL STORZ PLASTIC SURGERY ACCESSORIES received FDA 510(k) clearance on 1995-03-22, under 510(k) number K945889.

Who is the listed applicant for KARL STORZ PLASTIC SURGERY ACCESSORIES?

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 KARL STORZ PLASTIC SURGERY ACCESSORIES?

The FDA product code for KARL STORZ PLASTIC SURGERY ACCESSORIES is GCM.

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: GCM)

K203226TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MMRichard Wolf Medical Instruments Corporation K083840MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPEMsi Medserv International Deutschland GmbH K001217INSIDE VIEWMonadnock Optics, Inc.K993103ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREESRichard Wolf Medical Instruments Corp.K993445OMNISONIC ENDOSCOPIC DEFLECTOROmnisonics Medical Technologies K962393KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATIONKARL STORZ Endoscopy-America, Inc.

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.