Home / 510(k) Clearances / K881176

510(k) K881176

STERILE ESMARCH BANDAGE by Spectrum/Hydro-Med Products, Inc. — Product Code GAX

K881176 is an FDA 510(k) premarket notification submitted by Spectrum/Hydro-Med Products, Inc. for the device "STERILE ESMARCH BANDAGE". The FDA issued a decision of Substantially Equivalent on April 11, 1988. The device falls under product code GAX (Tourniquet, Nonpneumatic), a Class I device regulated under 21 CFR 878.5900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1988
Date Received
March 18, 1988
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 for product code GAX

  • K931198 — UNIQUET (September 1, 1993)
  • K881398 — TOURNIQUET (April 29, 1988)
  • K875092 — DEGANIA SILICONE TOURNIQUET (January 7, 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