Product Code: FFS
FDA class 2
21 CFR 876.1500
Image, Illumination, Fiberoptic, For Endoscope
Gastroenterology, Urology
The Fiberoptic Image and Illumination System for Endoscope is an accessory that transmits light and images through flexible optical fibers within an endoscope, enabling visualization of the gastrointestinal or urological tract. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party 510(k) review. The product code is FFS, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology specialty.
510(k)s
26
FEI Numbers
24
Registration Numbers
24
Unique Applicants
22
Years Active
24
Basic Information
- Product Code
- FFS
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 26 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | Nov 20, 2007 | Substantially Equivalent | COOK UROLOGICAL, INC. |
| K061622 | PS SERIES | Mar 05, 2007 | Substantially Equivalent | PHOTONIC OPTISCHE GERATE GESMBH & COKG |
| K063309 | TRU-CABLE | Jan 12, 2007 | Substantially Equivalent | TRUPHATEK INTERNATIONAL, LTD. |
| K061025 | ACCUTECH ENDOLITE PROBE | May 31, 2006 | Substantially Equivalent | ACCUTECH MEDICAL TECHNOLOGIES, INC. |
| K023633 | SOVIS OPTIQUE'S ENDOSCOPIC CABLE | Dec 31, 2002 | Substantially Equivalent | SOVIS OPTIQUE |
| K001698 | MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 | Jul 17, 2000 | Substantially Equivalent | COGENT LIGHT TECHNOLOGIES, INC. |
| K994084 | SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES | Jan 20, 2000 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K991323 | SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR | Jul 06, 1999 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K983714 | SOLARTEC SOURCE 270, MODEL # 90123 | Dec 23, 1998 | Substantially Equivalent | COGENT LIGHT TECHNOLOGIES, INC. |
| K982462 | FIBER OPTIC ENDOILLUMINATION PROBE | Sep 14, 1998 | Substantially Equivalent | MICROVISION, INC. |
| K980636 | FIBER OPTIC ENDOILLUMINATION PROBE | May 20, 1998 | Substantially Equivalent | DUTCH OPHTHALMIC USA, INC. |
| K970217 | VISTA ILLUMINATION SYSTEM | Apr 02, 1997 | Substantially Equivalent | VISTA MEDICAL TECHNOLOGIES, INC. |
| K962595 | KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS | Sep 04, 1996 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K950960 | REDDY ILLUMINATOR | Sep 08, 1995 | Substantially Equivalent | LUXTEC CORP. |
| K945102 | MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE | Nov 04, 1994 | Substantially Equivalent | ALM SURGICAL EQUIPMENT, INC. |
| K944688 | LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR | Nov 01, 1994 | Substantially Equivalent | PROGRESSIVE DYNAMICS, INC. |
| K940963 | XENON LIGHT SOURCE | Apr 08, 1994 | Substantially Equivalent | INCREDIVISION, INC. |
| K940962 | LIQUID LIGHT 500 | Apr 08, 1994 | Substantially Equivalent | INCREDIVISION, INC. |
| K933216 | KARL STORZ ENDOSCOPY-AMERICA, INC. | Sep 09, 1993 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K892145 | FIBER OPTIC LIGHT TRANSMISSION CABLE | Sep 29, 1989 | Substantially Equivalent | OPTO VISION, INC. |
| K893440 | FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150 | Jul 28, 1989 | Substantially Equivalent | WELCH ALLYN, INC. |
| K890448 | LIGHT SOURCE, ENDOSCOP, XENON ARC | May 08, 1989 | Substantially Equivalent | MIRA, INC. |
| K844773 | EFF-EFFNER BULBS | Jan 08, 1985 | Substantially Equivalent | MECRON MEDICAL PRODUCTS, INC. |
| K834576 | REAL FIBER OPTIC URETERAL TRANSILLUMIN | Apr 20, 1984 | Substantially Equivalent | DOUGLAS MANUFACTURER CO. |
| K840605 | LABORIE FIBREOPTIC LIGHT CABLE | Apr 13, 1984 | Substantially Equivalent | TRIDAK DIVISION OF INDICON, INC. |
| K834487 | FLEXIBLE LIQUID LIGHT GUIDE | Feb 21, 1984 | Substantially Equivalent | ENDO LASE, INC. |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.