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510(k) K951519

WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT by Wells Johnson Co. — Product Code FWL

K951519 is an FDA 510(k) premarket notification submitted by Wells Johnson Co. for the device "WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT". The FDA issued a decision of Substantially Equivalent on June 14, 1995. The device falls under product code FWL (Camera, Cine, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160. Wells Johnson Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1995
Date Received
April 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Cine, Endoscopic, Without Audio
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type

Other clearances by Wells Johnson Co.

  • K991437 — WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 (August 30, 1999)
  • K984448 — BIRCOLL BALLOON DISSECTOR (January 28, 1999)
  • K971580 — UAS ULTRASONIC ASPIRATOR SYSTEM (December 9, 1997)
  • K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (December 4, 1995)
  • K945500 — WELLS JOHNSON FIXATION SYSTEM (September 21, 1995)
  • K945877 — WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT (March 2, 1995)
  • K945805 — WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE (December 13, 1994)
  • K854068 — EXTERNAL MECHANICAL FASTENER (November 22, 1985)
  • K843188 — WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP (September 20, 1984)
  • K832519 — ASPIRATING TUBING (October 20, 1983)

Other clearances for product code FWL

  • K883760 — STORZ MODEL 62 ENT CAMERA SYSTEM (September 28, 1988)

FDA data resources