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510(k) K830511

ZANLEX, ZAN-TEX & ZANDEX by Winn Hirsch & Assoc. — Product Code GDY

K830511 is an FDA 510(k) premarket notification submitted by Winn Hirsch & Assoc. for the device "ZANLEX, ZAN-TEX & ZANDEX". The FDA issued a decision of Substantially Equivalent on March 17, 1983. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Winn Hirsch & Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1983
Date Received
February 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal, X-Ray Detectable
Device Class
Class I
Regulation Number
878.4450
Review Panel
SU
Submission Type

Other clearances by Winn Hirsch & Assoc.

  • K880309 — TYPE 316L STAINLESS STEEL WIRE (February 29, 1988)
  • K864375 — TYPE 316L COTTER WIRE (May 20, 1987)
  • K832213 — GAUZE CONVERSION CLASS II STERILE (July 26, 1983)
  • K832214 — GAUZE CONVERSION CLASS I-NON-STERILE (July 26, 1983)
  • K812391 — NEUROSPONGES (November 24, 1981)
  • K812390 — NEUROSPONGE PADDIE (November 24, 1981)
  • K800195 — COTTON UNDER CAST PADDING (February 11, 1980)
  • K761155 — CELLULOSE EYE STICK (December 16, 1976)
  • K760513 — ELECTRODE, TEMPORARY MYOCARDIAL (October 15, 1976)
  • K760365 — BLANKET, BURN (August 11, 1976)

Other clearances for product code GDY

  • K972634 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K960236 — CPR LAP SPONGES (March 28, 1996)
  • K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE (February 22, 1996)
  • K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE (December 19, 1995)
  • K953830 — KENSORB (October 3, 1995)
  • K953088 — TRIANGULAR SPONGES (September 14, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)
  • K953059 — KITTNER DISSECTOR (September 14, 1995)

FDA data resources