MINIATURE LAPAROSCOPE SET (MINI LAP)
Device Facts
| Record ID | K962799 |
|---|---|
| Device Name | MINIATURE LAPAROSCOPE SET (MINI LAP) |
| Applicant | Richard Wolf GmbH |
| Product Code | GCJ · Gastroenterology, Urology |
| Decision Date | Oct 11, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Miniature Laparoscope Set is used to apply and maintain pneumoperitoneum in the usual way, and to introduce telescopes and other auxiliary instruments, such as forceps and scissors for diagnostic and therapeutic purposes.
Device Story
Miniature Laparoscope Set; includes spring-loaded Veress cannula, tubes, and telescopes. Used for establishing/maintaining pneumoperitoneum and introducing auxiliary instruments (forceps, scissors). Operated by physicians in clinical/surgical settings. Provides visualization for diagnostic and therapeutic laparoscopic procedures. Benefits include minimally invasive access via miniaturized diameter and length instruments.
Clinical Evidence
No clinical data. Bench testing performed to verify spring-loaded cannula function and steam autoclave compatibility.
Technological Characteristics
Materials: medical grade stainless steel, chrome-plated brass, glass lenses, glass fibers, plastic (eyepiece). Design: miniaturized diameter and length for minimally invasive access. Energy: mechanical (spring-loaded). Sterilization: steam autoclaving.
Indications for Use
Indicated for patients undergoing minimally invasive laparoscopic diagnostic or therapeutic procedures requiring pneumoperitoneum and instrument access.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
Predicate Devices
- Richard Wolf pre-enactment devices
- Imagyn 510(k) devices
- Ethicon 510(k) devices
- Origin 510(k) devices
Related Devices
- K971420 — MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212) · Richard Wolf Medical Instruments Corp. · Oct 22, 1997
- K101733 — REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES · Sac, LLC Dba Pinnacle Medical Surgical · Jun 6, 2011
- K950335 — KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY · KARL STORZ Endoscopy-America, Inc. · May 16, 1996
- K062097 — VERESS CANNULA AND MODULAR VERESS CANNULA · PAJUNK GmbH Medizintechnologie · Oct 13, 2006
- K040855 — INSTRUMED LAPAROSCOPE AND ACCESSORIES · Instrumed International, Inc. · Apr 16, 2004
