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510(k) K952584

GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK by Gamp & Assoc. — Product Code MPA

K952584 is an FDA 510(k) premarket notification submitted by Gamp & Assoc. for the device "GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK". The FDA issued a decision of Substantially Equivalent on September 1, 1995. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Gamp & Assoc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1995
Date Received
June 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type

Other clearances by Gamp & Assoc.

  • K952585 — GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR (January 5, 1996)
  • K952569 — GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR (January 5, 1996)
  • K952581 — GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR (January 5, 1996)
  • K954307 — GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE (December 22, 1995)
  • K954308 — GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE (December 22, 1995)
  • K954306 — GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE (December 22, 1995)
  • K952586 — GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR (September 1, 1995)
  • K952580 — GAMP & ASSOCIATES DISPOSABLE BARE END FIBER (September 1, 1995)

Other clearances for product code MPA

  • K253468 — Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) (August 10, 2026)
  • K242184 — Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (806 (December 4, 2024)
  • K233653 — Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00) (August 5, 2024)
  • K221872 — ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System (March 30, 2023)
  • K202670 — Nam illumination probe with chopper (August 20, 2021)
  • K151604 — 23ga Chandelier Illuminator, 25ga Chandelier Illuminator (September 11, 2015)
  • K143123 — Synergetics PHOTON EX (February 24, 2015)
  • K080067 — ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER (July 18, 2008)
  • K062895 — XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII (October 13, 2006)
  • K062259 — ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 (August 15, 2006)

FDA data resources