Who is the manufacturer of KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR?

KARL STORZ Endoscopy-America, Inc. filed the 510(k) submission for KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR (K955756).

What is the FDA product code for KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR?

HGI. It is classified under 21 CFR 884.4120 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR?

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

Who can help prepare an FDA 510(k) submission like KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR?

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.

KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR

K955756 · KARL STORZ Endoscopy-America, Inc. · HGI · Nov 26, 1996 · Obstetrics/Gynecology

Device Facts

Record ID	K955756
Device Name	KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
Applicant	KARL STORZ Endoscopy-America, Inc.
Product Code	HGI · Obstetrics/Gynecology
Decision Date	Nov 26, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.4120
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The KSEA thermocoagulation accessories are designed to thermally coagulate tissue during laparoscopic surgical procedures in gynecology.

Device Story

Manually operated, reusable laparoscopic surgical accessories; includes point coagulator, crocodile forceps, and myoma enucleator. Used as adjuncts to laparoscopes for thermal tissue coagulation in gynecological surgery. Operated by surgeons in clinical/OR settings. Devices provide mechanical access and thermal energy delivery to target tissue; facilitates hemostasis or tissue destruction. No automated processing or software components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: surgical grade stainless steel. Form factor: long-shafted instruments for laparoscopic access. Energy: thermal coagulation. Reusable. No software or electronic components.

Indications for Use

Indicated for thermal tissue coagulation during laparoscopic gynecological surgical procedures.

Regulatory Classification

Identification

A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

Related Devices

K081553 — AED BIPOLAR FORCEPS, MODEL 13-1646 · National Advanced Endoscopy Devices, Inc. · Sep 29, 2008
K962083 — KARL STORZ REMORGIDA FORCEPS · KARL STORZ Endoscopy-America, Inc. · Nov 1, 1996
K012725 — TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES · Endo-Therapeutics, Inc. · Nov 8, 2001
K043013 — MILTEX LAPAROSCOPIC INSTRUMENTS · Miltex, Inc. · Mar 4, 2005
K052759 — DAN MONOPOLAR LAP ACCESSORIES · Dannoritzer Medizintechnik GmbH & Co. KG · Jun 14, 2006

Submission Summary (Full Text)

{0} Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500 Toll Free 800 421 0837 Fax 310 410 5527 K955756 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS NOV 26 1996 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 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 Laparoscopic Thermocoagulator accessories Trade Name Karl Storz Thermocoagulator accessories **Indication:** The KSEA thermocoagulation accessories are designed to thermally coagulate tissue during laparoscopic surgical procedures in gynecology. **Device Description:** The KSEA thermocoagulator accessories are manually operated, reusable surgical devices consisting of a point coagulator, crocodile forceps and a myoma enucleator. The instruments are long enough to gain access to the surgical area and are designed to be used as accessories to laparoscopes. The body contact materials are surgical grade stainless steel. **Substantial Equivalence:** The KSEA thermocoagulator accessories are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the KSEA thermocoagulator accessories 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: ![img-0.jpeg](img-0.jpeg) Betty M. Johnson Manager, Regulatory Affairs 000055