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510(k) K875092

DEGANIA SILICONE TOURNIQUET by Degania Silicone , Ltd. — Product Code GAX

K875092 is an FDA 510(k) premarket notification submitted by Degania Silicone , Ltd. for the device "DEGANIA SILICONE TOURNIQUET". The FDA issued a decision of Substantially Equivalent on January 7, 1988. The device falls under product code GAX (Tourniquet, Nonpneumatic), a Class I device regulated under 21 CFR 878.5900. Degania Silicone , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1988
Date Received
December 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Nonpneumatic
Device Class
Class I
Regulation Number
878.5900
Review Panel
SU
Submission Type

Other clearances by Degania Silicone , Ltd.

  • K254170 — Percutaneous Endoscopic Gastrostomy (PEG) Kit (March 20, 2026)
  • K233591 — Stylus (May 31, 2024)
  • K152246 — Aquarius Stoma Measuring Device (June 21, 2016)
  • K143378 — AQUARIUS Gastrostomy Replacement Tube (December 29, 2014)
  • K141753 — AQUARIUS NASAL FEEDING TUBE (October 16, 2014)
  • K141631 — AQUARIUS EXTENSION FEEDING SET (July 28, 2014)
  • K132686 — AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE (May 12, 2014)
  • K131020 — TEMPERATURE SENSOR CATHETER (May 9, 2013)
  • K122030 — LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON (September 5, 2012)
  • K103371 — COUDE/ OR TIEMANN (March 11, 2011)

Other clearances for product code GAX

  • K931198 — UNIQUET (September 1, 1993)
  • K881398 — TOURNIQUET (April 29, 1988)
  • K881176 — STERILE ESMARCH BANDAGE (April 11, 1988)
  • K873928 — UNIVERSAL TOURNIQUET (October 23, 1987)
  • K872003 — KINDERWRAP (June 23, 1987)
  • K864897 — DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 (January 12, 1987)
  • K853472 — FINGER TOURNIQUETTE (October 10, 1985)
  • K853537 — VELCRO TOURNIQUET (September 12, 1985)
  • K852277 — CATAPRESS TOURNIGUET (June 27, 1985)
  • K851482 — TOURNIQUET (April 29, 1985)

FDA data resources