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510(k) K925671

DISPOSABLE SCLERAL PLUGS by O.R. Specialties, Inc. — Product Code LXP

K925671 is an FDA 510(k) premarket notification submitted by O.R. Specialties, Inc. for the device "DISPOSABLE SCLERAL PLUGS". The FDA issued a decision of Substantially Equivalent on August 2, 1993. The device falls under product code LXP (Plug, Scleral), a Class II device regulated under 21 CFR 886.4155. O.R. Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1993
Date Received
November 10, 1992
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 O.R. Specialties, Inc.

  • K942607 — LAPAROSCOPIC SCISSORS (DISPOSABLE) (July 6, 1994)
  • K923630 — PHACO NEEDLES 1000-R & 1000-O NEEDLES (April 6, 1994)
  • K923887 — JACK'S VENT TUBES (February 19, 1993)
  • K923774 — DISPOSABLE ENDOILLUMINATOR (October 19, 1992)
  • K922355 — POLLY'S VITREOUS SCISSORS J-225-S (August 18, 1992)
  • K922180 — LEWICKY O.R.S. TUBING (July 2, 1992)
  • K914038 — POLLY'S CUTTER J-225 (December 9, 1991)
  • K911932 — J105 JAMES SURGICAL SYSTEM I/A PACK (August 26, 1991)
  • K890195 — JAMES SURGICAL SYSTEM J1000 (August 3, 1989)
  • K890825 — JUMPER PACK #203 (May 26, 1989)

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)
  • 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