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510(k) K972506

INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR by Infinitech, Inc. — Product Code HJM

K972506 is an FDA 510(k) premarket notification submitted by Infinitech, Inc. for the device "INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR". The FDA issued a decision of Substantially Equivalent on October 1, 1997. The device falls under product code HJM (Transilluminator, Ac-Powered), a Class II device regulated under 21 CFR 886.1945. Infinitech, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1997
Date Received
July 3, 1997
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 Infinitech, Inc.

  • K971950 — INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER (August 1, 1997)
  • K951627 — INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM (October 19, 1995)
  • K931264 — INFINITECH OTOPROBE (March 1, 1994)
  • K931546 — END-IRRIGATING ENDOILLUMINATOR (February 9, 1994)
  • K935441 — INFINITECH BREATH EZ (February 7, 1994)

Other clearances for product code HJM

  • K950529 — PEREGRINE DIFFUSION LIGHT PIPE (June 7, 1995)
  • K945877 — WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT (March 2, 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