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510(k) K922918

BARRIER SAF-TE HYDROGEL DRAPE by Johnson & Johnson International — Product Code KKX

K922918 is an FDA 510(k) premarket notification submitted by Johnson & Johnson International for the device "BARRIER SAF-TE HYDROGEL DRAPE". The FDA issued a decision of Substantially Equivalent on July 6, 1993. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Johnson & Johnson International has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1993
Date Received
June 18, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.

Other clearances by Johnson & Johnson International

  • K965198 — ULTIMA TPS CEMENTED STEM (July 23, 1997)
  • K944937 — SYNTHETIC ABSORBABLE SUTURE (May 19, 1995)
  • K946245 — TIELLE* HYDROPOLYMER DRESSING (April 11, 1995)
  • K942383 — DERMIVIEW CLEAR TAPE (August 22, 1994)
  • K923807 — P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS (November 9, 1992)
  • K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING (November 21, 1990)
  • K901456 — ORTHOSORB(R) ABSORBABLE PIN (August 15, 1990)
  • K900638 — P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT (April 30, 1990)
  • K895207 — BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM (September 28, 1989)

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)

FDA data resources