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510(k) K871604

MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS by Advanced Surgical Products, Inc. — Product Code LXP

K871604 is an FDA 510(k) premarket notification submitted by Advanced Surgical Products, Inc. for the device "MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS". The FDA issued a decision of Substantially Equivalent on June 12, 1987. The device falls under product code LXP (Plug, Scleral), a Class II device regulated under 21 CFR 886.4155. Advanced Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1987
Date Received
April 24, 1987
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 Advanced Surgical Products, Inc.

  • K030926 — FAST THROW STAINLESS STEEL SURGICAL SUTURE (July 21, 2003)
  • K895800 — ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR (January 22, 1990)
  • K896754 — I/A HANDPIECE (January 11, 1990)
  • K896305 — MULTI-USE I/A HANDPIECE (December 18, 1989)
  • K884557 — ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE (May 12, 1989)
  • K884556 — DREYER CURVED ENDOILLUMINATOR (February 28, 1989)
  • K890398 — RYAN-STYLE DIRECTED INFUSION MANIPULATOR (February 17, 1989)
  • K884347 — MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN (December 27, 1988)
  • K883856 — FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE (September 29, 1988)
  • K883857 — FIBEROPTIC WIRE PICK LIGHTPIPE (September 29, 1988)

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)
  • 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