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510(k) K012527

Device
KSEA SIALOENDOSCOPES AND ACCESSORIES
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
510(k) number
K012527
Product code
GCJ  
Decision
Substantially Equivalent (SESE)
Decision date
2001-11-01
Date received
2001-08-06
Regulation
876.1500
Classification name
Laparoscope, General & Plastic Surgery
Medical specialty
Gastroenterology/Urology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JAMES A LEE
Address
600 Corporate Pt.e Culver City CA US 90230 90230

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GCJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc2026-07-17
K261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.2026-07-14
K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.2026-06-11
K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.2026-06-10
K253994TroKit Laparoscope Lens WiperTroCare, LLC2026-06-04
K252532Inno-Port Disposable Bladed TrocarTaiwan Surgical Corporation2026-06-02
K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.2026-05-26
K260183MediBot Needle Driver UnoParallel Robotics, LLC2026-05-24
K252985LaportSejong Medical Co., Ltd.2026-05-19
K254228KARL STORZ Trocars with Valve SealsKarl Storz SE & CO. KG2026-05-11
K2528584K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd.2026-04-30
K260089TL-10 Laparoscopic Scope CleanerScopix , Ltd.2026-04-08
K260197Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)Suzhou Shenyun Medical Equipment Co., Ltd.2026-04-08
K252714C-Lant PortVigor Medical Technologies , Ltd.2026-02-27
K253978Universal Seal (5-12 mm)Intuitive Surgical, Inc.2026-02-24

Legacy Summary#

summary

FDA Review#

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