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510(k) K864375

TYPE 316L COTTER WIRE by Winn Hirsch & Assoc. — Product Code LRN

K864375 is an FDA 510(k) premarket notification submitted by Winn Hirsch & Assoc. for the device "TYPE 316L COTTER WIRE". The FDA issued a decision of SN on May 20, 1987. The device falls under product code LRN (Wire, Surgical), a Class II device regulated under 21 CFR 888.3030. Winn Hirsch & Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
May 20, 1987
Date Received
November 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Surgical
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Winn Hirsch & Assoc.

  • K880309 — TYPE 316L STAINLESS STEEL WIRE (February 29, 1988)
  • K832214 — GAUZE CONVERSION CLASS I-NON-STERILE (July 26, 1983)
  • K832213 — GAUZE CONVERSION CLASS II STERILE (July 26, 1983)
  • K830511 — ZANLEX, ZAN-TEX & ZANDEX (March 17, 1983)
  • K812390 — NEUROSPONGE PADDIE (November 24, 1981)
  • K812391 — NEUROSPONGES (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 LRN

  • K002755 — NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE (December 4, 2000)
  • K990355 — STAINLESS STEEL SOFT SUTURE WIRE (July 8, 1999)
  • K971682 — J-FX CERCLAGE SYSTEM (June 27, 1997)
  • K952783 — OXBORO-MEDICAL PIN COVERS (September 15, 1995)
  • K942603 — ORTHOPAEDIC WIRES (November 9, 1994)
  • K900926 — TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) (April 23, 1990)
  • K892651 — SONGER WIRING SYSTEM (July 25, 1989)

FDA data resources