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510(k) K940594

KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE by KARL STORZ Endoscopy-America, Inc. — Product Code FGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1994
Date Received
February 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Nephroscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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Other clearances for product code FGA

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  • K994223 — NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 (June 5, 2000)
  • K950433 — KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES (March 15, 1995)
  • K922826 — FLEXIBLE FIBER OPTIC ENDOSCOPE (February 19, 1993)
  • K853486 — OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE (September 12, 1985)
  • K791182 — ACMI RIGI-FLEX NEPHORSCOPE (July 30, 1979)
  • K770729 — PYELOSCOPE SYSTEM (April 28, 1977)