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510(k) K931072

HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE by Hgm, Inc. — Product Code HJM

K931072 is an FDA 510(k) premarket notification submitted by Hgm, Inc. for the device "HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE". The FDA issued a decision of Substantially Equivalent on November 10, 1994. The device falls under product code HJM (Transilluminator, Ac-Powered), a Class II device regulated under 21 CFR 886.1945. Hgm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1994
Date Received
March 2, 1993
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 Hgm, Inc.

  • K950120 — SMART PLUG (August 11, 1995)
  • K931784 — HGM ILLUMINATING IMAGING ENDOCULAR PROBE (March 1, 1994)
  • K933333 — HGM SCANMAN PLUS (September 23, 1993)
  • K931499 — Q-11 OPHTHALMIC LASER (August 19, 1993)
  • K925663 — HGM ASPIRATING ENDOOCULAR(TM) PROBE (August 17, 1993)
  • K930543 — E-25 KRYPTON ION LASER (SURGICA K5) (June 22, 1993)
  • K880908 — MODEL PC ARGON LASER (May 3, 1988)
  • K873773 — ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER (October 13, 1987)
  • K872630 — ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. (August 25, 1987)
  • K870773 — ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER (July 10, 1987)

Other clearances for product code HJM

  • K972506 — INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR (October 1, 1997)
  • K950529 — PEREGRINE DIFFUSION LIGHT PIPE (June 7, 1995)
  • K945877 — WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT (March 2, 1995)
  • 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