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510(k) K954306

GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE by Gamp & Assoc. — Product Code HQB

K954306 is an FDA 510(k) premarket notification submitted by Gamp & Assoc. for the device "GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE". The FDA issued a decision of Substantially Equivalent on December 22, 1995. The device falls under product code HQB (Photocoagulator And Accessories), a Class II device regulated under 21 CFR 886.4690. Gamp & Assoc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1995
Date Received
September 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photocoagulator And Accessories
Device Class
Class II
Regulation Number
886.4690
Review Panel
OP
Submission Type

Other clearances by Gamp & Assoc.

  • K952581 — GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR (January 5, 1996)
  • K952585 — GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR (January 5, 1996)
  • K952569 — GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR (January 5, 1996)
  • K954308 — GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE (December 22, 1995)
  • K954307 — GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE (December 22, 1995)
  • K952584 — GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK (September 1, 1995)
  • K952580 — GAMP & ASSOCIATES DISPOSABLE BARE END FIBER (September 1, 1995)
  • K952586 — GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR (September 1, 1995)

Other clearances for product code HQB

  • K220263 — Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex S (November 3, 2022)
  • K191846 — MAXReach Laser Probe (December 23, 2019)
  • K182646 — Vitreq disposable laser probes, light fibers and Chandelier (May 1, 2019)
  • K132614 — PEREGRINE CURVED ILLUMINATING LASER PROBE (November 14, 2013)
  • K122997 — 23GA CURVED ILLUMINATING LASER PROBE (June 26, 2013)
  • K122905 — PEREGRINE 23GA CURVED LASER PROBE (April 30, 2013)
  • K113857 — SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE (April 23, 2012)
  • K110951 — 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VAL (October 17, 2011)
  • K111493 — NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI (July 27, 2011)
  • K110228 — NIDEK MULTICOLOR LASER PHOTOCOAGULATOR (February 23, 2011)

FDA data resources