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510(k) K945877

WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT by Wells Johnson Co. — Product Code HJM

K945877 is an FDA 510(k) premarket notification submitted by Wells Johnson Co. for the device "WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT". The FDA issued a decision of Substantially Equivalent on March 2, 1995. The device falls under product code HJM (Transilluminator, Ac-Powered), a Class II device regulated under 21 CFR 886.1945. Wells Johnson Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1995
Date Received
December 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transilluminator, Ac-Powered
Device Class
Class II
Regulation Number
886.1945
Review Panel
OP
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)
  • K951519 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (June 14, 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 HJM

  • K972506 — INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR (October 1, 1997)
  • K950529 — PEREGRINE DIFFUSION LIGHT PIPE (June 7, 1995)
  • K931072 — HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE (November 10, 1994)
  • K933445 — DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) (September 23, 1994)
  • K940393 — PEREGRINE WIDE ANGLE LIGHT PIPE (September 2, 1994)
  • K934269 — FIBEROPTIC ILLUMINATED INSTRUMENTS (May 17, 1994)
  • K913273 — DROLITE(TM) LIGHT SOURCE (December 4, 1991)
  • K894513 — DIATHRON(R) DIATHERMY UNIT (October 31, 1989)
  • K893170 — VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) (June 5, 1989)
  • K812949 — RMI TRANSILLUMINATOR, MODEL 292 (December 2, 1981)

FDA data resources