K962881 · Karl Storz Endoscopy · HEW · Oct 22, 1996 · Obstetrics/Gynecology
Device Facts
Record ID
K962881
Device Name
KSEA CULDOCENTESIS SET
Applicant
Karl Storz Endoscopy
Product Code
HEW · Obstetrics/Gynecology
Decision Date
Oct 22, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.1640
Device Class
Class 2
Indications for Use
The KSEA Culdocentesis Set are intended for use by qualified surgeons or physicians in the collection of peritoneal fluid.
Device Story
Manual reusable surgical device; includes two single-use disposable components. Used by surgeons or physicians for peritoneal fluid collection. Device facilitates fluid aspiration; minimizes complications associated with conventional culdocentesis. Clinical utility involves fluid sampling for diagnostic purposes.
Indicated for use by qualified surgeons or physicians for the collection of peritoneal fluid.
Regulatory Classification
Identification
A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.
Submission Summary (Full Text)
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Karl Storz Endoscopy
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
K962881
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
**Applicant:**
Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500
**OCT 22 1996**
**Contact:**
Kevin Kennan
Regulatory Affairs Specialist
**Device Identification:**
Common Name: Culdocentesis Set
Trade Name: (optional)
KSEA Culdocentesis Set
**Indication:** The KSEA Culdocentesis Set are intended for use by qualified surgeons or physicians in the collection of peritoneal fluid.
**Device Description:** The KSEA Culdocentesis Set are manual reusable surgical devices (with two single-use disposable components). The KSEA Culdocentesis Set provides a high success rate in the collection of peritoneal fluid, while minimizing the problems of conventional culdocentesis. The body contact materials are surgical grade stainless steel, PTFE, and polyurethane. The non-body contact materials of the Culdocentesis Set are silicone, polyolefin, and PVC.
**Substantial Equivalence:** The KSEA Culdocentesis for collection of peritoneal fluid are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA Culdocentesis Set and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed:
Kevin Kennan
Regulatory Affairs Specialist
000081
