EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)
Device Facts
| Record ID | K964334 |
|---|---|
| Device Name | EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) |
| Applicant | Shippert Medical Technologies Corp. |
| Product Code | GCJ · Gastroenterology, Urology |
| Decision Date | Dec 9, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
Intended Use
The Expandacell™ Anti-Fog Instrument Wipe is intended for use in surgery to prevent fogging on medical instruments.
Device Story
Expandacell™ Anti-Fog Instrument Wipe; used in surgical settings to prevent fogging on medical instruments; applied by surgical staff; maintains clear visualization during procedures; benefits patient by ensuring uninterrupted surgical performance.
Clinical Evidence
No clinical data; device is identical to legally marketed predicates with established track record.
Technological Characteristics
Anti-fog wipe; identical in materials and physical construction to predicate devices.
Indications for Use
Indicated for use in surgical procedures to prevent fogging on medical instruments.
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
- Xomed/Merocel Anti-Fog Instrument Wipe (K923843/A)
- Dixide, Inc. Anti-Fog Instrument Wipe (K791736)
Related Devices
- K974454 — CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 · Tucson Medical Corp. · Dec 18, 1997
- K973558 — VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) · Ultracell Medical Technologies, Inc. · Nov 24, 1997
- K152948 — Medline Anti-Fog Solution · Medline Industries, Inc. · Feb 4, 2016
- K251068 — KnoxFog Anti-fogging Device · Uv One Hygienics, Inc. · Aug 27, 2025
- K960621 — EXPANDACELL INSTRUMENT WIPE · Shippert Medical Technologies Corp. · Apr 1, 1996
