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510(k) K901530

WALLACE INTRAUTERINE INSEMINATION CATHETER by Gynescope Corp. — Product Code EJT

K901530 is an FDA 510(k) premarket notification submitted by Gynescope Corp. for the device "WALLACE INTRAUTERINE INSEMINATION CATHETER". The FDA issued a decision of Substantially Equivalent on July 23, 1990. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Gynescope Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1990
Date Received
April 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by Gynescope Corp.

  • K902657 — GYNESCOPE LAPAROSCOPIC FORCEPS (September 19, 1990)
  • K902658 — GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES (September 19, 1990)
  • K902655 — GYNESCOPE LAPAROSCOPES (July 13, 1990)
  • K902656 — GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES (June 29, 1990)
  • K902019 — MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS (June 7, 1990)
  • K902049 — CROAK OVARIAN BIOPSY FORCEP (June 7, 1990)
  • K900878 — OTT INSUFFLATION FILTER TUBING (May 7, 1990)
  • K895225 — GYNECOLOGICAL INSTRUMENTATION (March 5, 1990)

Other clearances for product code EJT

  • K052463 — PROMETAL HN86 (October 14, 2005)
  • K041378 — BIO 60 (August 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (March 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, (March 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)

FDA data resources