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510(k) K922826

FLEXIBLE FIBER OPTIC ENDOSCOPE by Optimed Technologies, Inc. — Product Code FGA

K922826 is an FDA 510(k) premarket notification submitted by Optimed Technologies, Inc. for the device "FLEXIBLE FIBER OPTIC ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on February 19, 1993. The device falls under product code FGA (Kit, Nephroscope), a Class II device regulated under 21 CFR 876.1500. Optimed Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1993
Date Received
June 11, 1992
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

Other clearances by Optimed Technologies, Inc.

  • K972520 — OPTIVIEW (September 29, 1997)
  • K955275 — BOOSTER TROPHY 5 MOTORIZED SCOOTER (November 4, 1996)
  • K955276 — BOOSTER LITE 4 MOTORIZED SCOOTER (November 4, 1996)
  • K955274 — BOOSTER LITE 3 MOTORIZED SCOOTER (November 4, 1996)
  • K943598 — FLEXIBLE FIBER OPTIC LAPAROSCOPES (October 18, 1994)
  • K926597 — LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) (July 12, 1994)
  • K921942 — HYSTEROSCOPE (AND ACCESSORIES) (June 24, 1994)
  • K922711 — FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE (May 17, 1994)
  • K921985 — ARTHROSCOPE & ACCESSORIES (June 29, 1993)
  • K921883 — ENDOSCOPE (November 23, 1992)

Other clearances for product code FGA

  • K232370 — Percutaneous Nephroscope System (May 1, 2024)
  • K151308 — Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (February 9, 2016)
  • K072594 — GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM (December 13, 2007)
  • 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)
  • K940594 — KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE (September 9, 1994)
  • K853486 — OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE (September 12, 1985)
  • K791182 — ACMI RIGI-FLEX NEPHORSCOPE (July 30, 1979)
  • K770729 — PYELOSCOPE SYSTEM (April 28, 1977)

FDA data resources