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510(k) K880345

CYSTOTOMES/KNIFES by Myocure, Inc. — Product Code HNY

K880345 is an FDA 510(k) premarket notification submitted by Myocure, Inc. for the device "CYSTOTOMES/KNIFES". The FDA issued a decision of Substantially Equivalent on May 3, 1988. The device falls under product code HNY (Cystotome), a Class I device regulated under 21 CFR 886.4350. Myocure, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1988
Date Received
January 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystotome
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Myocure, Inc.

  • K880347 — ANESTHESIA/RETROBULBAR NEEDLES (May 3, 1988)
  • K880346 — CANNULAS (May 3, 1988)
  • K874057 — OPHTHALMIC TIP & BLADE SCALPELS (December 23, 1987)
  • K874056 — OPHTHALMIC DISPOSABLE BLADES (December 22, 1987)
  • K873385 — OPHTHALMIC PHACO-BLADE (September 21, 1987)
  • K864371 — SURGICAL SKIN MARKER (November 17, 1986)
  • K863663 — OPHTHALMIC SURGICAL OCULAR MARKERS (October 20, 1986)
  • K863662 — OPHTHALMIC SURGICAL DRAPE (October 20, 1986)
  • K863666 — THE SAVER KIT (October 20, 1986)
  • K863665 — THE ULTIMATE (September 25, 1986)

Other clearances for product code HNY

  • K961524 — STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPU (May 16, 1996)
  • K874976 — PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K874975 — PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME (April 13, 1988)
  • K874997 — PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME (April 13, 1988)
  • K874983 — PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME (April 13, 1988)
  • K874993 — PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K875001 — PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME (April 13, 1988)
  • K873163 — VAN DELLEN IRRIGATING CYSTOTOME (September 4, 1987)
  • K871365 — CAPSULECTOMER CYSTOTOME (April 16, 1987)
  • K870439 — LOOK IRRIGATING CYSTOTOMES (February 20, 1987)

FDA data resources