Laparoscope, Gynecologic (and Accessories)

Product Code: HET

Obstetrics/Gynecology General Optical Products / Medical

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 884.1720


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as HET

3918Laparoscope, Gynecologic (and Accessories)Gynecologic Laparoscope And Accessories.

Total Product Life Cycle (TPLC) Devices

3918Laparoscope, Gynecologic (and Accessories)Gynecologic Laparoscope And Accessories.

FDA Consensus Standards

Laparoscope, Gynecologic (And Accessories) [32386]21 CFR §884.1720 🔎
Laparoscope, Gynecologic (And Accessories) [30564]21 CFR §884.1720 🔎
Laparoscope, Gynecologic (And Accessories) [30563]21 CFR §884.1720 🔎
Laparoscope, Gynecologic (And Accessories) [33513]21 CFR §884.1720 🔎
Laparoscope, Gynecologic (And Accessories) [31951]21 CFR §884.1720 🔎

Pre-market Notifications for HET

K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.
K210104SurroundScope System270Surgical Ltd.
K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.
K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))Schoelly Fiberoptic GmbH
K200638LAP-iX Suction IrrigationSejong Medical Co., Ltd.
K2002164K UHD Camera SystemScivita Medical Technology Co., Ltd.
K190744ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)Olympus Winter & Ibe GmbH
K190190WV1 Endoscope270Surgical Ltd
K173111LAP-iX Suction IrrigationSejong Medical Co., Ltd.
K172796Flex Robotic System And Flex Transabdominal DriveMEDROBOTICS CORPORATION
K163320LAP-Pump PP110W.O.M. WORLD OF MEDICINE GMBH
K151011VISERA 4K UHD SYSTEMOlympus Medical Systems Corp.
K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ ENDOSCOPY-AMERICA, INC.
K131656MORCELLEX SIGMA GENERATORETHICON, INC.
K123365OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190OLYMPUS MEDICAL SYSTEMS CORP.

Global Unique Device Identification Database

10607915124523Laparoscope, Gynecologic (And Accessories)
10607915124516Laparoscope, Gynecologic (And Accessories)
00607915119768Laparoscope, Gynecologic (And Accessories)
00607915117375Laparoscope, Gynecologic (And Accessories)
10607915117327Laparoscope, Gynecologic (And Accessories)
10607915116771Laparoscope, Gynecologic (And Accessories)
10607915116764Laparoscope, Gynecologic (And Accessories)
10607915115187Laparoscope, Gynecologic (And Accessories)
10607915115170Laparoscope, Gynecologic (And Accessories)
10607915115163Laparoscope, Gynecologic (And Accessories)
10607915115156Laparoscope, Gynecologic (And Accessories)
00607915114282Laparoscope, Gynecologic (And Accessories)
10607915110137Laparoscope, Gynecologic (And Accessories)
10607915110120Laparoscope, Gynecologic (And Accessories)
20653405050183LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Maude Adverse Events

CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BXAPPLIED MEDICAL RESOURCES2020-03-03
CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BXAPPLIED MEDICAL RESOURCES2020-03-03
METZENBAUM SCISSORS INSERTRICHARD WOLF GMBH2020-02-27
CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BXAPPLIED MEDICAL RESOURCES2020-02-26
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2020-02-24
ENDOPLUS/SNOWDEN PENCERENDOPLUS2020-02-11
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2020-01-24
SLIDE-LOCK NR ATRAU GRASPER DBL-ACT 5MMCAREFUSION, INC2020-01-23
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2020-01-15
CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BXAPPLIED MEDICAL RESOURCES2019-12-13
CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BXAPPLIED MEDICAL RESOURCES2019-12-13
ENDO MINI-SHEARSUS SURGICAL PUERTO RICO2019-11-26
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2019-11-15
ENDO MINI-SHEARSUS SURGICAL PUERTO RICO2019-10-28
DISPOSABLE CHECK-FLO ADAPTERCOOK INC.2019-10-25
DISPOSABLE CHECK-FLO ADAPTERCOOK, INC.2019-10-25
DISPOSABLE CHECK-FLO ADAPTERCOOK INC.2019-10-25
DISPOSABLE CHECK-FLO ADAPTERCOOK INC.2019-10-25
AHTOSTRYKER ENDOSCOPY2019-09-12
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2019-08-21
ENDOPLUSENDOPLUS2019-08-16
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2019-08-12
LINA POWER MORCELLATORLINA MEDICAL APS2019-06-27
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2019-05-30
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2019-05-30
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2019-05-30
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2019-05-30
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2019-05-30
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2019-05-30
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2019-05-28
EPIX LAPAROSCOPIC SCISSORSAPPLIED MEDICAL RESOURCES CORPORATION2019-05-16
CLASSIC BIPOLAR TUBAL FCPSSCIS5MM45CMAESCULAP INC2019-05-09
BIPOLAR CABLE F/CLASSIC BIP FCPS-VALLEYAESCULAP INC2019-05-09
CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BXAPPLIED MEDICAL RESOURCES2019-05-09
LINA POWER MORCELLATORLINA MEDICAL APS2019-04-03
SCISSORS "HIQ+", 5 X 330 MM, MINI-METZENBAUM, ERGOOLYMPUS WINTER & IBE GMBH2019-03-13
LINA POWER MORCELLATORLINA MEDICAL APS2019-03-12
ATRAUMATIC BOWEL GRASPER ERAGONRICHARD WOLF GMBH2019-03-06
CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BXAPPLIED MEDICAL RESOURCES2019-02-28
MORCELLATOR LINA XCISE 15MM LAPSCPLINA MEDICAL APS2019-02-27
CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BXAPPLIED MEDICAL RESOURCES2019-02-27
MORCELLATORUNKNOWN2019-02-27
MORCELLATOR LINA XCISE 15MM LAPSCPLINA MEDICAL2019-02-27
VERESS INSUFFLATION NEEDLE 150MMAESCULAP AG2019-02-20
MOTOR POWER PLUS CONTROL UNITRICHARD WOLF GMBH2019-02-14
GYNECARE X-TRACT MORCELLATOR UNKNOWN PRODUCTETHICON INC.2019-01-11
GYNECARE X-TRACT MORCELLATOR UNKNOWN PRODUCTETHICON INC.2019-01-11
GYNECARE X-TRACT MORCELLATOR UNKNOWN PRODUCTETHICON INC.2019-01-11
UNKUNKAPPLIED MEDICAL RESOURCES2019-01-10
GYNECARE MORCELLEX UNKNOWN PRODUCTETHICON INC.2019-01-10

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