FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
K Number: K032598
·
Decision Nov 24, 2003
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
39
Applicant Total
16
Review Days
91
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Basic Information
- Device Name
- SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
- K Number
- K032598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synergetics, Inc.
- Date Received
- August 25, 2003
- Decision Date
- November 24, 2003
- Product Code
- MPA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MPA | Endoilluminator | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MPA), ordered by most recent decision date.
Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
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Other Clearances by Synergetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K121426 | AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS | Jul 10, 2012 | Substantially Equivalent |
| K121675 | VERSAVIT | Jun 21, 2012 | Substantially Equivalent |
| K113857 | SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE | Apr 23, 2012 | Substantially Equivalent |
| K110924 | DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS | Dec 7, 2011 | Substantially Equivalent |
| K091441 | SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET | Oct 30, 2009 | Substantially Equivalent |
| K071482 | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 | Dec 20, 2007 | Substantially Equivalent |
| K063489 | STRYKER INTRADISCAL RF GENERATOR | May 23, 2007 | Substantially Equivalent |
| K020220 | ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE | Aug 23, 2002 | Substantially Equivalent |
| K010637 | SONOTOME ULTRASONIC ASPIRATOR TIPS | Apr 20, 2001 | Substantially Equivalent |
| K990568 | SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01 | May 14, 1999 | Substantially Equivalent |