Home / 510(k) Clearances / K945102

510(k) K945102

MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE by Alm Surgical Equipment, Inc. — Product Code FFS

K945102 is an FDA 510(k) premarket notification submitted by Alm Surgical Equipment, Inc. for the device "MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on November 4, 1994. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Alm Surgical Equipment, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1994
Date Received
October 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image, Illumination, Fiberoptic, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Alm Surgical Equipment, Inc.

  • K982063 — ALM PRISMALIX (PRX) SURGICAL LIGHT (September 22, 1998)
  • K961886 — DRAGER GEMINA WALL-MOUNTED WORKPLACE (July 30, 1996)
  • K961742 — DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM (July 26, 1996)
  • K942043 — DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E (July 13, 1994)
  • K922409 — ALM ILLUMINATOR SERIES LIGHT SYSTEM (January 12, 1993)
  • K921297 — DRAGER DVE 4000 SERIES SYSTEM (November 27, 1992)
  • K921848 — BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT (October 1, 1992)
  • K884019 — ALM OPERATING TABLES (October 13, 1988)
  • K882613 — ALM SURGICAL LAMPS (July 18, 1988)

Other clearances for product code FFS

  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (November 20, 2007)
  • K061622 — PS SERIES (March 5, 2007)
  • K063309 — TRU-CABLE (January 12, 2007)
  • K061025 — ACCUTECH ENDOLITE PROBE (May 31, 2006)
  • K023633 — SOVIS OPTIQUE'S ENDOSCOPIC CABLE (December 31, 2002)
  • K001698 — MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 (July 17, 2000)
  • K994084 — SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES (January 20, 2000)
  • K991323 — SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR (July 6, 1999)
  • K983714 — SOLARTEC SOURCE 270, MODEL # 90123 (December 23, 1998)
  • K982462 — FIBER OPTIC ENDOILLUMINATION PROBE (September 14, 1998)

FDA data resources