Product code HEW— Obstetrics/Gynecology

FDA has cleared 18 devices under product code HEW between 1996 and 2025, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20251 clearance
• 20201 clearance
• 20191 clearance
• 20181 clearance
• 20161 clearance
• 20152 clearances
• 20121 clearance
• 20111 clearance
• 20052 clearances
• 20041 clearance
• 20002 clearances
• 19981 clearance
• 19971 clearance
• 19962 clearances

• CooperSurgical, Inc.4 clearances
• KARL STORZ Endoscopy-America, Inc.2 clearances
• Applied Medical Resources Corp.2 clearances
• Surgitools Pty , Ltd.1 clearance
• Soprane S.A.1 clearance
• Richard Wolf Medical Instruments Corp.1 clearance
• Lsi Solutions, Inc.1 clearance
• Karl Storz Endoscopy1 clearance
• J.Singh Instruments1 clearance
• Insitu Systems1 clearance

• K243152 — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceApplied Medical Resources Corp.·2025-10-02
• K201086 — Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.·2020-05-21
• K191294 — Transvaginal Access PlatformApplied Medical Resources Corp.·2019-09-06
• K180429 — Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.·2018-03-14
• K161065 — ColpoWave Colpotomizer and CerviGrip Uterine ManipulatorSurgitools Pty , Ltd.·2016-10-27
• K143308 — GelPOINT Transvaginal Access PlatformApplied Medical Resources·2015-10-13
• K143650 — CooperSurgical Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.·2015-07-21
• K111014 — LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIESLsi Solutions, Inc.·2012-07-13
• K110819 — SINGHMED ROOLIP MANIPULATORJ.Singh Instruments·2011-10-05
• K051160 — MANIPUSEALInsitu Systems·2005-09-02
• K051594 — MCCARTNEY ACCESS TUBEGynetech Pty. , Ltd.·2005-09-02
• K033728 — TRANSVAGINAL ENDOSCOPY SETKARL STORZ Endoscopy-America, Inc.·2004-02-27
• K992655 — FERTILOSCOPY KIT FH 1.29/FTO 1.40Soprane S.A.·2000-03-13
• K993804 — KSEA RIGID CULDOSCOPE AND ACCESSORIESKARL STORZ Endoscopy-America, Inc.·2000-02-07
• K980972 — RIGID CULDOSCOPE AND ACCESSORIESCircon Corp.·1998-06-12
• K964276 — ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATORRichard Wolf Medical Instruments Corp.·1997-11-25
• K954311 — KOH COLPOTOMIZER SYSTEMCooperSurgical, Inc.·1996-11-19
• K962881 — KSEA CULDOCENTESIS SETKarl Storz Endoscopy·1996-10-22