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510(k) K860936

ABSORBENT, FIBER, OPERATING ROOM TOWELS by Ulti-Med Intl., Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1986
Date Received
March 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Ulti-Med Intl., Inc.

  • K103011 — ULTICARE SAFETY INSULIN SYRINGE (February 2, 2011)
  • K923175 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K920989 — SURGICAL INSTRUMENT KIT, DISPOSABLE (October 19, 1992)
  • K922828 — ULCER WOUND TRAY (September 28, 1992)
  • K914244 — STERILE CUSTOM SURGICAL KITS (February 24, 1992)
  • K914431 — ABSORBENT FIBER (December 4, 1991)
  • K912692 — CONFORMING BANDAGE (October 4, 1991)
  • K912693 — POST OPERATIVE SPONGE (October 4, 1991)
  • K904896 — EYE PAD (December 5, 1990)

Other clearances for product code KKX

  • K230645 — BeneHold™ Surgical Incise Drape with CHG antimicrobial II (October 25, 2023)
  • K222578 — 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
  • K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)