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510(k) K840693

DISPOSABLE SCLERAL GLOBE PLUG by Innovative Surgical Products, Inc. — Product Code LXP

K840693 is an FDA 510(k) premarket notification submitted by Innovative Surgical Products, Inc. for the device "DISPOSABLE SCLERAL GLOBE PLUG". The FDA issued a decision of Substantially Equivalent on May 22, 1984. The device falls under product code LXP (Plug, Scleral), a Class II device regulated under 21 CFR 886.4155. Innovative Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1984
Date Received
February 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plug, Scleral
Device Class
Class II
Regulation Number
886.4155
Review Panel
OP
Submission Type

Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.

Other clearances by Innovative Surgical Products, Inc.

  • K843041 — HESLIN DISPOS. TUBING SET (November 21, 1984)
  • K840695 — PHACOEMULSIFICATION KITS (May 22, 1984)
  • K840694 — LENS INSERTION GLIDE (May 9, 1984)
  • K841072 — IRRIGATION, ASPIRATION TUBING SETS (March 29, 1984)
  • K832235 — DISPOSABLE VITRECTOMY HANDPIECE (September 29, 1983)
  • K821496 — DISPOSABLE IRRIGA/ASPIR. SYSTEM (June 22, 1982)
  • K820765 — PLEURAL DRAINAGE RESERVOIR (April 15, 1982)
  • K820680 — DISPOSABLE TUBING SETS (April 9, 1982)
  • K802973 — ISPVAC TM (December 19, 1980)
  • K801350 — ACUVAC(TM) SUCTION RESERVOIR 400CC AND (July 14, 1980)

Other clearances for product code LXP

  • K022186 — SCLERAL PLUGS, 19 AND 20 GAUGE (February 26, 2003)
  • K990872 — SCLERAL PLUGS, 19 AND 20 GAUGE (July 13, 1999)
  • K945114 — VISITEC SCLERAL PLUG (February 23, 1995)
  • K925671 — DISPOSABLE SCLERAL PLUGS (August 2, 1993)
  • K880953 — ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG (May 13, 1988)
  • K880952 — PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS (May 13, 1988)
  • K871604 — MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS (June 12, 1987)
  • K854507 — STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS (February 7, 1986)
  • K831193 — SCLERAL PLUG (June 30, 1983)

FDA data resources