KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES

Q: Who is the manufacturer of KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES?

KARL STORZ Endoscopy-America, Inc. filed the 510(k) submission for KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES (K951343).

Q: What is the FDA product code for KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES?

HET. It is classified under 21 CFR 884.1720 as a Class 2 device in the Obstetrics/Gynecology panel.

Q: What is the regulatory pathway for KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K951343 · KARL STORZ Endoscopy-America, Inc. · HET · Apr 11, 1996 · Obstetrics/Gynecology

Device Facts

Record ID	K951343
Device Name	KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES
Applicant	KARL STORZ Endoscopy-America, Inc.
Product Code	HET · Obstetrics/Gynecology
Decision Date	Apr 11, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1720
Device Class	Class 2

Intended Use

The Karl Storz Semi-Rigid Micro-Endoscopes and Accessories are designed to allow viewing of, and access to, the surgical site during endoscopic gynecological surgical procedures.

Device Story

Straight-shafted fiberoptic endoscopes; used for visualization and access during gynecological surgery. Accessories include forceps, scissors, probes, trocars, cannulae, and needles. Operated by physicians in clinical/surgical settings. Provides direct optical visualization of surgical site to assist in diagnostic or therapeutic procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use similarity to existing devices.

Technological Characteristics

Fiberoptic endoscope; straight-shafted design. Materials are standard medical-grade biocompatible materials. Accessories include mechanical instruments (forceps, scissors, probes, trocars, cannulae, needles).

Indications for Use

Indicated for patients undergoing endoscopic gynecological surgical procedures requiring visualization and access to the surgical site.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. 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 preheater, light source and cables, and component parts.

Related Devices

K950335 — KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY · KARL STORZ Endoscopy-America, Inc. · May 16, 1996
K031974 — ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 · Asap Endoscopic Products GmbH · Sep 29, 2003
K990372 — MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY · Dr. Fritz GmbH · Oct 14, 1999
K993103 — ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES · Richard Wolf Medical Instruments Corp. · Dec 10, 1999
K012869 — GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 · Gimmi GmbH · Mar 11, 2002

Submission Summary (Full Text)

{0} K951343 APR 11 1996 # SUMMARY OF SAFETY AND EFFECTIVENESS 000162 {1} Karl Storz Endoscopy America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500 Toll Free 800 42 0837 Fax 310 410 552 K951343 # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 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 CRF 807.92. All data included in this documents are accurate and complete to the best of KSEA's knowledge ## Applicant: Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500 ## Contact: Betty M. Johnson Manager, Regulatory Affairs ## Device Identification: Common Name: fiberoptic endoscopes and accessories Trade Name (optional): Karl Storz Semi-Rigid Micro-Endoscopes and Accessories ## Indication: The Karl Storz Semi-Rigid Micro-Endoscopes and Accessories are designed to allow viewing of, and access to, the surgical site during endoscopic gynecological surgical procedures. ## Device Description: Karl Storz Semi-Rigid Micro-Endoscopes are straight-shafted, fiberoptic endoscopes. Accessories are available for use with the Micro-Endoscopes, including forceps, scissors, probes, trocars, cannulae, and needles. The body contact materials present in these devices are commonly used in medical devices for a wide range of applications, and have a long history of biocompatibility for human use. ## Substantial Equivalence: The Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for endoscopic gynecological surgery are substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for Endoscopic Gynecological Surgery 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 the devices. Signed: Betty M. Johnson Manager, Regulatory Affairs 000163