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510(k) K881669

MVR/STILETTO BLADE 20GA. - P/N 1900 by Advanced Surgical Products, Inc. — Product Code HNN

K881669 is an FDA 510(k) premarket notification submitted by Advanced Surgical Products, Inc. for the device "MVR/STILETTO BLADE 20GA. - P/N 1900". The FDA issued a decision of Substantially Equivalent on May 13, 1988. The device falls under product code HNN (Knife, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Advanced Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1988
Date Received
April 18, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

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 HNN

  • K110166 — CLEARCUT S SAFETY KNIFE (May 20, 2011)
  • K922378 — OPHTHALMIC KNIFE (December 10, 1992)
  • K882402 — RETRACTIVE INCISION MICROMETER (RIM) GUAGE (August 22, 1988)
  • K874979 — PRISMA DISPOSABLE MVR/STILETTO BLADE (April 13, 1988)
  • K874057 — OPHTHALMIC TIP & BLADE SCALPELS (December 23, 1987)
  • K874056 — OPHTHALMIC DISPOSABLE BLADES (December 22, 1987)
  • K873385 — OPHTHALMIC PHACO-BLADE (September 21, 1987)
  • K871285 — KNIFE, OPHTHALMIC (April 27, 1987)
  • K864290 — RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE (December 15, 1986)
  • K863725 — CATARACT DIAMOND KNIFE (October 31, 1986)

FDA data resources