Atlas FDA

HEW

18 FDA 510(k) clearances · Product code

195 daysmedian time to decision
431 days90th percentile
18clearances measured

FDA profile

Official device name
Culdoscope (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1640
Medical specialty
Obstetrics/Gynecology
Adverse events (MAUDE)
2021: 14 · 2022: 23 · 2023: 18 · 2024: 32 · 2025: 20 · 2026: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (K243152)Applied Medical Resources Corp.2025-10-02
Advincula Delineator Uterine Manipulator (K201086)CooperSurgical, Inc.2020-05-21
Transvaginal Access Platform (K191294)Applied Medical Resources Corp.2019-09-06
Advincula Delineator Uterine Manipulator (K180429)CooperSurgical, Inc.2018-03-14
ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator (K161065)Surgitools Pty , Ltd.2016-10-27
GelPOINT Transvaginal Access Platform (K143308)Applied Medical Resources2015-10-13
CooperSurgical Advincula Delineator Uterine Manipulator (K143650)CooperSurgical, Inc.2015-07-21
LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES (K111014)Lsi Solutions, Inc.2012-07-13
SINGHMED ROOLIP MANIPULATOR (K110819)J.Singh Instruments2011-10-05
MANIPUSEAL (K051160)Insitu Systems2005-09-02
MCCARTNEY ACCESS TUBE (K051594)Gynetech Pty. , Ltd.2005-09-02
TRANSVAGINAL ENDOSCOPY SET (K033728)KARL STORZ Endoscopy-America, Inc.2004-02-27
FERTILOSCOPY KIT FH 1.29/FTO 1.40 (K992655)Soprane S.A.2000-03-13
KSEA RIGID CULDOSCOPE AND ACCESSORIES (K993804)KARL STORZ Endoscopy-America, Inc.2000-02-07
RIGID CULDOSCOPE AND ACCESSORIES (K980972)Circon Corp.1998-06-12
ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR (K964276)Richard Wolf Medical Instruments Corp.1997-11-25
KOH COLPOTOMIZER SYSTEM (K954311)CooperSurgical, Inc.1996-11-19
KSEA CULDOCENTESIS SET (K962881)Karl Storz Endoscopy1996-10-22

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Every clearance here is in the API, with alerts when new ones post.