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510(k) K990872

SCLERAL PLUGS, 19 AND 20 GAUGE by Ophthalmic Consultants, Inc. — Product Code LXP

K990872 is an FDA 510(k) premarket notification submitted by Ophthalmic Consultants, Inc. for the device "SCLERAL PLUGS, 19 AND 20 GAUGE". The FDA issued a decision of Substantially Equivalent on July 13, 1999. The device falls under product code LXP (Plug, Scleral), a Class II device regulated under 21 CFR 886.4155. Ophthalmic Consultants, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1999
Date Received
March 16, 1999
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 Ophthalmic Consultants, Inc.

  • K990292 — I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY P (November 19, 1999)

Other clearances for product code LXP

  • K022186 — SCLERAL PLUGS, 19 AND 20 GAUGE (February 26, 2003)
  • 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)
  • K831193 — SCLERAL PLUG (June 30, 1983)

FDA data resources