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510(k) K770387

UNICATCH by W.G. Whitney Corp. — Product Code FMH

K770387 is an FDA 510(k) premarket notification submitted by W.G. Whitney Corp. for the device "UNICATCH". The FDA issued a decision of Substantially Equivalent on April 5, 1977. The device falls under product code FMH (Container, Specimen, Sterile), a Class I device regulated under 21 CFR 864.3250. W.G. Whitney Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1977
Date Received
February 28, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
HO
Submission Type

Other clearances by W.G. Whitney Corp.

  • K834532 — STERILE WET DRESSING PACK (January 25, 1984)
  • K813535 — XEROFORM DRESSING (February 4, 1982)
  • K810406 — STERILE WET DRESSING PACK (March 11, 1981)
  • K803299 — COLD/HOT PACK (January 15, 1981)
  • K800907 — TOMAC WET DRESSING WARMER (May 20, 1980)
  • K781322 — STERILE WET DRESSING PACK (August 17, 1978)

Other clearances for product code FMH

  • K900983 — TRI-TECH URINE SPECIMEN KIT (September 17, 1990)
  • K823763 — VARIOUS-SPECIMEN COLLECTORS (January 19, 1983)
  • K820180 — CALCULI FILTER CUP (February 5, 1982)
  • K812933 — LANCER SPECIMEN CONTAINER (November 6, 1981)
  • K802340 — SPECIMEN SET (October 10, 1980)
  • K802002 — URINE SPECIMEN CONTAINER #'S 1013-1016 (September 9, 1980)
  • K800947 — MIDSTREAM COLLECTION KIT (May 30, 1980)
  • K800309 — SPECIMEN COLLECTION PAN (February 26, 1980)
  • K800233 — ABCO MIDSTREAM URINE COLLECTION SET (February 26, 1980)
  • K792710 — PARA-PAK CLEAN VIAL (January 28, 1980)

FDA data resources