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510(k) K896383

DISPOSABLE EXTERNAL CLAMPS by Galenica Enterprises, Inc. — Product Code GDI

K896383 is an FDA 510(k) premarket notification submitted by Galenica Enterprises, Inc. for the device "DISPOSABLE EXTERNAL CLAMPS". The FDA issued a decision of Substantially Equivalent on December 6, 1989. The device falls under product code GDI (Dissector, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Galenica Enterprises, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1989
Date Received
November 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dissector, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Galenica Enterprises, Inc.

  • K923656 — LIGHTING SOURCE SYSTEM (September 8, 1994)
  • K883283 — DISPOSABLE AMNIOTOME (October 18, 1988)
  • K861017 — GALENICA'S DISPOSABLE ANOSCOPES (June 13, 1986)
  • K841909 — VAGINAL SPECULUM - DISPOSABLE (July 31, 1984)

Other clearances for product code GDI

  • K850288 — HEPATIC PARENCHYMAL SUCTION DISSECTOR (March 18, 1985)
  • K831912 — ROUND-BEEHIVE- DISSECTORS 3/8 (October 31, 1983)
  • K822569 — TYMPANOPLASTY & SKIN DISSECTORS (October 6, 1982)
  • K803292 — FIELD SUCTION DISSECTOR (January 29, 1981)
  • K791870 — DISPOSABLE SPECIALITY SPONGES (November 5, 1979)
  • K791703 — TEW BYPASS INSTRUMENTS & DISSECTING KIT (October 4, 1979)

FDA data resources