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510(k) K831193

SCLERAL PLUG by Medical Instrument Development Laboratories, Inc. — Product Code LXP

K831193 is an FDA 510(k) premarket notification submitted by Medical Instrument Development Laboratories, Inc. for the device "SCLERAL PLUG". The FDA issued a decision of Substantially Equivalent on June 30, 1983. The device falls under product code LXP (Plug, Scleral), a Class II device regulated under 21 CFR 886.4155. Medical Instrument Development Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
April 12, 1983
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 Medical Instrument Development Laboratories, Inc.

  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K020911 — MID LABS AUTONOMOUS VIT ENHANCER (AVE) (April 29, 2002)
  • K992943 — VIT ENHANCER (December 10, 1999)
  • K971067 — DIGI-INJECTOR (September 19, 1997)
  • K950287 — UNIVIT PROBE (April 10, 1995)
  • K934600 — MICRODRIVE (July 27, 1994)
  • K932669 — SUPRA-VIT(TM) (June 3, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K924222 — MID LABS, INC. VIT MATE (January 27, 1993)

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)
  • K880952 — PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS (May 13, 1988)
  • K880953 — ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG (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)
  • K840693 — DISPOSABLE SCLERAL GLOBE PLUG (May 22, 1984)

FDA data resources