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510(k) K871365

CAPSULECTOMER CYSTOTOME by Noetix, Inc. — Product Code HNY

K871365 is an FDA 510(k) premarket notification submitted by Noetix, Inc. for the device "CAPSULECTOMER CYSTOTOME". The FDA issued a decision of Substantially Equivalent on April 16, 1987. The device falls under product code HNY (Cystotome), a Class I device regulated under 21 CFR 886.4350. Noetix, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1987
Date Received
April 7, 1987
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 Noetix, Inc.

  • K893992 — NOETIX, BIOPSY NEEDLE (September 8, 1989)
  • K881635 — NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM (July 1, 1988)

Other clearances for product code HNY

  • K961524 — STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPU (May 16, 1996)
  • K880345 — CYSTOTOMES/KNIFES (May 3, 1988)
  • K874983 — PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME (April 13, 1988)
  • K874976 — PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K874997 — PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME (April 13, 1988)
  • K874993 — PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K874975 — PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME (April 13, 1988)
  • K875001 — PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME (April 13, 1988)
  • K873163 — VAN DELLEN IRRIGATING CYSTOTOME (September 4, 1987)
  • K870439 — LOOK IRRIGATING CYSTOTOMES (February 20, 1987)

FDA data resources