Product Code: HEW FDA class 2 21 CFR 884.1640

Culdoscope (And Accessories)

Obstetrics/Gynecology

The Culdoscope (and accessories) is an endoscope introduced through the posterior vaginal wall (cul-de-sac) to visualize the pelvic and abdominal contents, used historically as an alternative to laparoscopy for gynecological diagnosis and minor surgical procedures. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HEW, regulated under 21 CFR 884.1640, within the Obstetrics/Gynecology specialty. No special risk flags apply.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code HEW in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: HEW
Device Class: FDA class 2
Regulation Number: 884.1640
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243152	GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device	Oct 02, 2025	Substantially Equivalent	Applied Medical Resources Corp.
K201086	Advincula Delineator Uterine Manipulator	May 21, 2020	Substantially Equivalent	CooperSurgical, Inc.
K191294	Transvaginal Access Platform	Sep 06, 2019	Substantially Equivalent	Applied Medical Resources Corp.
K180429	Advincula Delineator Uterine Manipulator	Mar 14, 2018	Substantially Equivalent	CooperSurgical, Inc.
K161065	ColpoWave Colpotomizer and CerviGrip Uterine Manipulator	Oct 27, 2016	Substantially Equivalent	Surgitools Pty , Ltd.
K143308	GelPOINT Transvaginal Access Platform	Oct 13, 2015	Substantially Equivalent	Applied Medical Resources
K143650	CooperSurgical Advincula Delineator Uterine Manipulator	Jul 21, 2015	Substantially Equivalent	CooperSurgical, Inc.
K111014	LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES	Jul 13, 2012	Substantially Equivalent	Lsi Solutions, Inc.
K110819	SINGHMED ROOLIP MANIPULATOR	Oct 05, 2011	Substantially Equivalent	J.Singh Instruments
K051594	MCCARTNEY ACCESS TUBE	Sep 02, 2005	Substantially Equivalent	Gynetech Pty. , Ltd.
K051160	MANIPUSEAL	Sep 02, 2005	Substantially Equivalent	Insitu Systems
K033728	TRANSVAGINAL ENDOSCOPY SET	Feb 27, 2004	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K992655	FERTILOSCOPY KIT FH 1.29/FTO 1.40	Mar 13, 2000	Substantially Equivalent	Soprane S.A.
K993804	KSEA RIGID CULDOSCOPE AND ACCESSORIES	Feb 07, 2000	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K980972	RIGID CULDOSCOPE AND ACCESSORIES	Jun 12, 1998	Substantially Equivalent	Circon Corp.
K964276	ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR	Nov 25, 1997	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K954311	KOH COLPOTOMIZER SYSTEM	Nov 19, 1996	Substantially Equivalent	CooperSurgical, Inc.
K962881	KSEA CULDOCENTESIS SET	Oct 22, 1996	Substantially Equivalent	Karl Storz Endoscopy